TS V2
Biomerieux
Created on September 25, 2024
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Transcript
This troubleshooting guide is for help purposes only.It does not replace the package inserts, user manual, and instructions for use.The latest versions of these documents are available on the Resource Center: resourcecenter.biomerieux.com
INTERNAL USE ONLY
- Functional Defect: A defect that affects the fit, form, or function of the bottle, rendering it unusable for the customer. bioMérieux advises against using bottles with functional defects.
- Cosmetic Defect: A defect that only affects the visual appearance of the bottle. Bottles with cosmetic defects can be used.
INTERNAL USE ONLY
CAP, CRIMP, AND STOPPER
CULTURE MEDIA
LABEL
SENSOR
BOTTLE PLASTIC
VACUUM
INTERNAL USE ONLY
INTERNAL USE ONLY
ON THE STOPPER
ON THE CRIMP
ON THE FLIP CAP
INTERNAL USE ONLY
IT' S FALLEN (it is in the box)
IT' S MISSING (not in the box)
IT'S DEFECTIVE
INTERNAL USE ONLY
YES, IT'S DAMAGED / APPEARS SMALLER
NO, IT'S UNDAMAGED
INTERNAL USE ONLY
IT'S MISSING
IT'S PUNCTURED
INTERNAL USE ONLY
IT'S CUT
IT'S LOOSE
IT'S DENTED OR BUMPED
INTERNAL USE ONLY
IT COULD BE COMPROMISED
IT'S NOT COMPROMISED
INTERNAL USE ONLY
MICROBIAL CONTAMINATION BEFORE INOCULATION
SMALL IRREGULAR PARTICLES WITH NO SIGN OF MICROBIAL CONTAMINATION
OTHER PARTICLES
INTERNAL USE ONLY
VOIDS ARE PRESENT
THERE ARE RUN DRIPS
THERE IS SEEPAGE
SLIGHT DISCOLORATION OF SENSOR
THE SENSOR IS SLANTED / UNEVEN / UNCURED
INTERNAL USE ONLY
YES
NO
INTERNAL USE ONLY
NO
YES
INTERNAL USE ONLY
NO
YES
INTERNAL USE ONLY
COLLAPSED BOTTLE
WAVE IN BOTTLE NECK
BURN MARKS
POLYCARBONATE PARTICLES
NYLON BUBBLES
MATERIAL OUTSIDE OF BOTTLES
HAZE / CLOUDY PLASTIC BOTTLE
SUPERFICIAL SCRATCH
WHITE SEAM LINE
BREAK, CRACK, DEEP SCRATCH
INTERNAL USE ONLY
NO
INTERNAL USE ONLY
YES
≥ 10 mm
< 10 mm
INTERNAL USE ONLY
≥ 2 mm
< 2 mm
INTERNAL USE ONLY
YES
NO
INTERNAL USE ONLY
NO
INTERNAL USE ONLY
YES
NO
INTERNAL USE ONLY
YES
GATE DROOL
BURN MARKS
POLYCARBONATE DEBRIS
NYLON BUBBLES
BULGING (CONVEX ON OPTICAL REGION)
BREAK, CRACK, SCRATCH
INTERNAL USE ONLY
≥ 11 mm
< 11 mm
INTERNAL USE ONLY
PROMINENT / BOW TIE
EMBEDDED / LIGHT
INTERNAL USE ONLY
SOLID
LIGHT
INTERNAL USE ONLY
NO
YES
INTERNAL USE ONLY
INTERNAL USE ONLY
CSNs:
- 4932 - CSN - BACTALERT - Culture Bottle Two Sensor Anomalies - LES Voids LES Drips Runs
- CSN 2024-785-0 - BACT/ALERT® BOTTLES - CHANGE NOTIFICATION PROCESS - ACCEPTABLE COSMETIC VARIABILITY
- CSN 3906 - BACTALERT - Culture Bottles - Two Plastic Bottle Cosmetic Defects.
- 5292 - CSN - BACT/ALERT Plastic Bottle Impact Testing
INTERNAL USE ONLY
INTERNAL USE ONLY
COSMETIC DEFECT
ERROR CODES
BOTTLE PLASTIC DEFECT -COLLAPSED - B266
No escalation is needed
COSMETIC DEFECT
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
No escalation is needed
OPERATOR RISK / POTENTIAL FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE CRIMP DEFECT - FUNCTIONAL - B258
POTENTIAL FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE FLIP CAP ISSUE - B380
COSMETIC DEFECT
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
No escalation is needed
CRITICAL FUNCTIONAL DEFECT
Escalate a CRM Case ASAP
ERROR CODES
BOTTLE CONTAMINATION UNINOCULATED - B104
COSMETIC DEFECT
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
No escalation is needed
COSMETIC DEFECT
ERROR CODES
BOTTLE CONTAM UNINOCULATED-PARTICULATE - B214
No escalation is needed
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE SENSOR DEFECT - SEEPAGE - B356
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE STOPPER DEFECT - B111
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE STOPPER DEFECT - MISSING - B270
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE PLASTIC DEFECT -COLLAPSED - B266
COSMETIC DEFECT
ERROR CODES
PLASTIC BOTTLE DEFECT - EXTERNAL DEBRIS - B374
No escalation is needed
Inoculation is disturbed because of a too small piercing zone:
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE PLASTIC DEFECT - B109orBROKEN BOTTLE -B101
COSMETIC DEFECT
ERROR CODES
BOTTLE PLASTIC DEFECT -COLLAPSED - B266
No escalation is needed
OPERATOR ERROR
The customer must be retrained.No escalation is needed.
ERROR CODES
BOTTLE INOCULATION - B89 orBOTTLE INOCULATION - IMPROPER NEEDLE - B261
COSMETIC DEFECT
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
No escalation is needed
POTENTIAL FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE CRIMP DEFECT - FUNCTIONAL - B258
COSMETIC DEFECT
ERROR CODES
BOTTLE SENSOR DEFECT - LES RUN/DRIP - B269
No escalation is needed
COSMETIC DEFECT
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
No escalation is needed
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE INOCULATION - VACUUM - B260
COSMETIC DEFECT
No escalation is needed
ERROR CODES
BOTTLE SENSOR DEFECT - B110
POTENTIAL FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE PLASTIC DEFECT - BULGING - B265
COULD BE A FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
POTENTIAL FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE CONTAM UNINOCULATED-PARTICULATE - B214
COSMETIC DEFECT
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
No escalation is needed
COSMETIC DEFECT
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
No escalation is needed
SENSOR
POTENTIAL FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
COSMETIC DEFECT
ERROR CODES
BOTTLE BARCODE DEFECT - B100BOTTLE LABEL ABSENT - B105BOTTLE LABEL MISALIGNED - B106LABELING PROBLEM - BOTTLE DOUBLE LABEL - B378LABELING PROBLEM - BOTTLE PULL TAB - B379....
No escalation is needed
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE SENSOR DEFECT - LES VOIDS - B357
FLIP CAP
CRIMP
Classic crimp come with a Flip Cap
Removable crimp for iAST and iLYM bottles (no Flip Cap)
Without
With
STOPPER
SEPTUM
LABEL
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE CRIMP DEFECT - FUNCTIONAL - B258
COSMETIC DEFECT
No escalation is needed
ERROR CODES
BOTTLE FLIP CAP ISSUE - B380
NORMAL VARIABILITY
No need to qualify the case as a TC
Refer to CSN 2024-785
COSMETIC DEFECT
ERROR CODES
BOTTLE CRIMP DEFECT - COSMETIC- B259
No escalation is needed
COSMETIC DEFECT
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
No escalation is needed
COSMETIC DEFECT
ERROR CODES
BOTTLE PLASTIC DEFECT - BUBBLES - B358
No escalation is needed
NORMAL VARIABILITY
No need to qualify the case as a TC
Refer to CSN 2024-785
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE PLASTIC DEFECT - B109
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE BARCODE DEFECT - B100BOTTLE LABEL ABSENT - B105BOTTLE LABEL MISALIGNED - B106LABELING PROBLEM - BOTTLE DOUBLE LABEL - B378LABELING PROBLEM - BOTTLE PULL TAB - B379....
COSMETIC DEFECT
ERROR CODES
BOTTLE SENSOR DEFECT - LES VOIDS - B357
No escalation is needed
COSMETIC DEFECT
ERROR CODES
BOTTLE PLASTIC DEFECT - BUBBLES - B358
No escalation is needed
NORMAL VARIABILITY
No need to qualify the case as a TC
Refer to CSN 2024-785
Weak cap where the ring remains on the septum:
FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
PLASTIC BOTTLE DEFECT - EXTERNAL DEBRIS - B374
POTENTIAL FUNCTIONAL DEFECT
Escalate a CRM Case
ERROR CODES
BOTTLE SENSOR DEFECT - SLANT - B268