BACT/ALERT® FA PLUS CULTURE BOTTLE
Report
- Report Number
- 3002769706-2018-00204
- Event Type
- Malfunction
- Date Received
- October 10, 2018
- Report Date
- January 8, 2019
- Manufacturer
- BIOMERIEUX INC.
- Product Code
- MDB
- UDI-DI
- 03573026357900
- PMA / PMN Number
- K121461
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: BACT/ALERT® FA PLUS LOT 4050853 BOTTLE WAS INCUBATED FOR 9.6 DAYS. THE SENSOR WAS YELLOW AND YEAST FUNGUS WAS VERIFIED BY GRAM STAINING AND STAINING WITH ACRIDINE ORANGE. THE PATIENT HAD A FEVER AND NEUROFIBROMATOSIS, AND WAS PREVIOUSLY DIAGNOSED WITH CANDIDA ALBICANS. THE PATIENT WAS BEING TREATED WITH MEROPENEM, VANCOMYCIN, AND A FUNGICIDE BECAUSE THE PATIENT WAS DIAGNOSED WITH A YEAST INFECTION. ON 24SEP18 A BACKUP WAS REQUESTED AND DETAILS REGARDING THE FUNGICIDE WERE ALSO REQUESTED. ON 19OCT18 ADDITIONAL INFORMATION REGARDING THE PATIENT TREATMENT WAS RECEIVED. THE PATIENT WAS ON MICAFUNGIN BY THE TIME THE BOTTLE WAS INOCULATED. ON 06DEC18 THE BACKUP WAS EVALUATED BY GLOBAL CUSTOMER SERVICE (GCS). THERE WAS NO INSTRUMENT MALFUNCTIONS FOUND WHEN EVALUATING THE BACT/ALERT® 3D BACKUP. BIOMATH REVIEWED THE EXTRACTED DATA. THE ALGOTOOL DETERMINED THAT THE GRAPH LOOK POSITIVE FOR THE BOTTLE ID ARRJ5RP8. BASED ON THE ALGOTOOL OUTPUT, THE ALGORITHM DETECTED SLOW GROWTH BUT THE GROWTH IS TOO SLOW TO REACH THE DETECTION THRESHOLD SET FOR THE BACT/ALERT® FA PLUS BOTTLE. ON 24OCT18, REVIEW OF THE MANUFACTURING DIRECTIONS (MD) WAS CONDUCTED BY THE INVESTIGATOR AT THE DURHAM, NC FACILITY. THE REVIEW ENCOMPASSED AN EVALUATION OF THE FILLING LOT BACT/ALERT® FA PLUS 4050851, LABELING AND PACKAGING (FINISHED PRODUCT BACT/ALERT® FA PLUS LOT 4050853) AND PROCESSES AND INSPECTIONS. THE REVIEW INCLUDED A REVIEW OF THE COMPLETE BOTTLE FORM, RACK/STACK INSPECTION FORM, AND PACKAGING DEFECT LOG. ALL INSPECTIONS MET ATTRIBUTE LIMITS. QC MICROBIOLOGY, BIOCHEMISTRY, AND ENVIRONMENTAL MONITORING (EM)/ BIOBURDEN TESTING WERE PERFORMED ON BACT/ALERT® FA PLUS LOT 4050851 IN ACCORDANCE WITH INTERNAL SPECIFICATIONS. THE RESULTS MET THE SPECIFICATIONS. FINISHED GOODS BACT/ALERT® FA PLUS BOTTLE, PART NUMBER (P/N) 410851, LOT NUMBER 4050853 MET ALL RELEASE CRITERIA, WAS REVIEWED BY QUALITY ASSURANCE (QA) AND 3788 CASES WERE RELEASED FOR DISTRIBUTION TO THE FIELD ON 18MAY18. INSTRUCTIONS FOR USE (IFU) REVIEW BACT/ALERT® FA PLUS IFU, 9312050 E - 2016-04 WAS REVIEWED BY THE INVESTIGATOR ON 02JUL18. SPECIMEN COLLECTION AND PREPARATION GENERAL CONSIDERATIONS 4. BIOMÉRIEUX RECOMMENDS THAT INOCULATED CULTURE BOTTLES BE PLACED INTO THE BACT/ALERT MICROBIAL DETECTION SYSTEM AS SOON AS POSSIBLE AFTER COLLECTION. IF THERE IS AN UNAVOIDABLE DELAY, INOCULATED BOTTLES MAY BE MAINTAINED AT ROOM TEMPERATURE UP TO 24 HOURS BEFORE LOADING INTO THE INSTRUMENT. PROCEDURAL NOTES AND PRECAUTIONS 3. IF INOCULATED CULTURE BOTTLES HAVE BEEN DELAYED IN THEIR RECEIPT INTO THE LABORATORY OR HAVE BEEN INCUBATED PRIOR TO ENTRY INTO THE BACT/ALERT INSTRUMENT, VISUALLY INSPECT FOR INDICATIONS OF MICROBIAL GROWTH. IF MICROBIAL GROWTH IS EVIDENT, TREAT THE BOTTLES AS POSITIVE AND DO NOT PLACE IN THE BACT/ALERT MICROBIAL DETECTION SYSTEM FOR MONITORING. 5. OPTIMAL RECOVERY OF ISOLATES WILL BE ACHIEVED BY ADDING MAXIMUM AMOUNTS OF SPECIMEN. USE OF LOWER VOLUMES MAY ADVERSELY AFFECT RECOVERY AND/OR DETECTION TIMES OF SOME ORGANISMS. DO NOT FILL ABOVE THE BOTTLE'S MAXIMUM SPECIMEN VOLUME OF 10 ML. THE VACUUM IN THE BOTTLE WILL USUALLY EXCEED10 ML; MONITOR THE VOLUME COLLECTED BY MEANS OF THE 5 ML INCREMENTAL MARKINGS ON THE BOTTLE LABEL. LABORATORY PROCEDURE 1.VISUALLY INSPECT BOTTLES BEFORE TESTING. DO NOT USE BOTTLES WITH EVIDENCE OF DAMAGE, LEAKAGE, OR DETERIORATION. CONSIDER BOTTLES WITH HEMOLYSIS, TURBIDITY, EXCESS GAS PRESSURE, YELLOW SENSORS, AND/OR EVIDENCE OF GROWTH AS POSITIVE. SMEAR AND SUBCULTURE. DO NOT INCUBATE UNLESS SMEAR IS NEGATIVE. 4. NEGATIVE BOTTLES MAY BE CHECKED BY SMEAR AND/OR SUBCULTURE AT SOME POINT PRIOR TO DISCARDING AS NEGATIVE. LIMITATIONS OF THE TEST MANY VARIABLES INVOLVED IN BLOOD CULTURE TESTING CANNOT BE PRACTICALLY CONTROLLED TO PROVIDE TOTAL CONFIDENCE THAT RESULTS OBTAINED ARE DUE SOLELY TO PROPER OR IMPROPER PERFORMANCE OF ANY CULTURE MEDIUM OR DETECTION SYSTEM. PRODUCT RETURNS NO BOTTLES WERE REQUESTED TO BE RETURNED AS A RESULT OF THIS INVESTIGATION, THE CUSTOMERS SUB-CULTURED THE INOCULATED BOTTLES. PRODUCT RETAINS RETAIN BOTTLE VISUAL INSPECTION WAS NOT PERFORMED ON RETAIN SAMPLE SINCE THE COMPLAINT WAS NOT ABOUT VISUAL ASPECTS OF THE PRODUCT. ROOT CAUSE ANALYSIS ON 04DEC18, A CROSS FUNCTIONAL TEAM (CFT) COMPRISED OF GLOBAL CUSTOMER SERVICE, QUALITY ASSURANCE, INDUSTRIALIZATION AND RESEARCH AND DEVELOPMENT MICROBIOLOGY, MET TO BRAINSTORM AND DETERMINE ROOT CAUSE FOR THE FALSE NEGATIVE RESULTS. THE INFORMATION IN THE COMPLAINT AND THE GRAPHS PROVIDED BY THE CUSTOMER WERE REVIEWED AND DISCUSSED, AS WELL AS THE INFORMATION PROVIDED IN THE IFU, THE INFORMATION PROVIDED BY BIOMATH AND THE RESULTS OF THE MD REVIEW, AND TRENDING. NO TRENDS FOR FALSE NEGATIVE RESULTS FOR CANDIDA ALBICANS IN BACT/ALERT® FA PLUS BOTTLES WERE IDENTIFIED. THE REVIEW OF THE MD FOUND THE LOTS PASSED WITH NO GROWTH PERFORMANCE ISSUES. THE TEAM REVIEWED THE INFORMATION AND TROUBLESHOOTING PROVIDED IN THE COMPLAINT. THE BOTTLES WERE INOCULATED AT ONE LOCATION AND TRANSPORTED TO A DIFFERENT LOCATION PRIOR TO LOADING ON THE INSTRUMENT. THE INOCULATED BOTTLES MAY HAVE BEEN EXPOSED TO TEMPERATURES ABOVE ROOM TEMPERATURE DURING TRANSPORT FROM ONE SITE TO THE OTHER. THERE IS NO INFORMATION REGARDING EXAMINATION OF THE BOTTLE SENSOR PRIOR TO LOADING INTO THE INSTRUMENT AFTER THE DELAY BUT THE INITIAL REFLECTANCE READINGS WERE NOT HIGH ENOUGH TO CAUSE A YELLOW SENSOR; GROWTH OCCURRED AFTER LOADING, BUT WAS SLOWER THAN NORMAL. BIOMÉRIEUX DURHAM TESTED FOUR C. ALBICANS ISOLATES PROVIDED BY THE CUSTOMER UNDER FOUR CONDITIONS, NO DELAY, NO DELAY WITH THE ADDITION OF HUMAN BLOOD, EIGHT HOUR DELAY WITH THE ADDITION OF 10 ML HUMAN BLOOD AND 24 HOUR DELAY WITH THE ADDITION OF HUMAN BLOOD. THE BACT/ALERT FA PLUS BOTTLE LOT ASSOCIATED WITH EACH COMPLAINT WAS TESTED FOR EACH ISOLATE. GROWTH WAS DETECTED BY THE BACT/ALERT INSTRUMENT IN ALL CASES AND NEITHER HUMAN BLOOD NOR DELAYED ENTRY HAD A NEGATIVE IMPACT ON DETECTION. THE SLOW RATE OF REFLECTANCE CHANGE AT THE CUSTOMER SITE WAS INSUFFICIENT FOR THE ALGORITHM TO DECLARE THE BOTTLES POSITIVE. THE 100% RECOVERY AND RAPID TIMES TO DETECTION WHEN TESTED BY BIOMÉRIEUX IN DURHAM SUGGESTS THAT THE ORGANISMS WERE STRESSED, INHIBITED OR DAMAGED IN THE PATIENT'S SAMPLE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. TREND REVIEW THE ANALYSIS OF COMPLAINT DATA FOUND NO COMPLAINT, CAPA OR NONCONFORMANCE TRENDS RELATED TO THIS INVESTIGATION.
AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: BACT/ALERT® FA PLUS LOT 4050853 BOTTLE WAS INCUBATED FOR 9.6 DAYS. THE SENSOR WAS YELLOW AND YEAST FUNGUS WAS VERIFIED BY GRAM STAINING AND STAINING WITH ACRIDINE ORANGE. THE PATIENT HAD A FEVER AND NEUROFIBROMATOSIS, AND WAS PREVIOUSLY DIAGNOSED WITH CANDIDA ALBICANS. THE PATIENT WAS BEING TREATED WITH MEROPENEM, VANCOMYCIN, AND A FUNGICIDE BECAUSE THE PATIENT WAS DIAGNOSED WITH A YEAST INFECTION. ON 24SEP18 A BACKUP WAS REQUESTED AND DETAILS REGARDING THE FUNGICIDE WERE ALSO REQUESTED. ON 19OCT18 ADDITIONAL INFORMATION REGARDING THE PATIENT TREATMENT WAS RECEIVED. THE PATIENT WAS ON MICAFUNGIN BY THE TIME THE BOTTLE WAS INOCULATED. ON 06DEC18 THE BACKUP WAS EVALUATED BY GLOBAL CUSTOMER SERVICE (GCS). THERE WAS NO INSTRUMENT MALFUNCTIONS FOUND WHEN EVALUATING THE BACT/ALERT® 3D BACKUP. BIOMATH REVIEWED THE EXTRACTED DATA. THE ALGOTOOL DETERMINED THAT THE GRAPH LOOK POSITIVE FOR THE BOTTLE ID (B)(6). BASED ON THE ALGOTOOL OUTPUT, THE ALGORITHM DETECTED SLOW GROWTH BUT THE GROWTH IS TOO SLOW TO REACH THE DETECTION THRESHOLD SET FOR THE BACT/ALERT® FA PLUS BOTTLE. ON 24OCT18, REVIEW OF THE MANUFACTURING DIRECTIONS (MD) WAS CONDUCTED BY THE INVESTIGATOR AT THE DURHAM, NC FACILITY. THE REVIEW ENCOMPASSED AN EVALUATION OF THE FILLING LOT BACT/ALERT® FA PLUS 4050851, LABELING AND PACKAGING (FINISHED PRODUCT BACT/ALERT® FA PLUS LOT 4050853) AND PROCESSES AND INSPECTIONS. THE REVIEW INCLUDED A REVIEW OF THE COMPLETE BOTTLE FORM, RACK/STACK INSPECTION FORM, AND PACKAGING DEFECT LOG. ALL INSPECTIONS MET ATTRIBUTE LIMITS. QC MICROBIOLOGY, BIOCHEMISTRY, AND ENVIRONMENTAL MONITORING (EM)/ BIOBURDEN TESTING WERE PERFORMED ON BACT/ALERT® FA PLUS LOT 4050851 IN ACCORDANCE WITH INTERNAL SPECIFICATIONS. THE RESULTS MET THE SPECIFICATIONS. FINISHED GOODS BACT/ALERT® FA PLUS BOTTLE, PART NUMBER (P/N) 410851, LOT NUMBER 4050853 MET ALL RELEASE CRITERIA, WAS REVIEWED BY QUALITY ASSURANCE (QA) AND 3788 CASES WERE RELEASED FOR DISTRIBUTION TO THE FIELD ON 18MAY18. INSTRUCTIONS FOR USE (IFU) REVIEW: BACT/ALERT® FA PLUS IFU, 9312050 E - 2016-04 WAS REVIEWED BY THE INVESTIGATOR ON 02JUL18. SPECIMEN COLLECTION AND PREPARATION: GENERAL CONSIDERATIONS: BIOMÉRIEUX RECOMMENDS THAT INOCULATED CULTURE BOTTLES BE PLACED INTO THE BACT/ALERT MICROBIAL DETECTION SYSTEM AS SOON AS POSSIBLE AFTER COLLECTION. IF THERE IS AN UNAVOIDABLE DELAY, INOCULATED BOTTLES MAY BE MAINTAINED AT ROOM TEMPERATURE UP TO 24 HOURS BEFORE LOADING INTO THE INSTRUMENT. PROCEDURAL NOTES AND PRECAUTIONS: IF INOCULATED CULTURE BOTTLES HAVE BEEN DELAYED IN THEIR RECEIPT INTO THE LABORATORY OR HAVE BEEN INCUBATED PRIOR TO ENTRY INTO THE BACT/ALERT INSTRUMENT, VISUALLY INSPECT FOR INDICATIONS OF MICROBIAL GROWTH. IF MICROBIAL GROWTH IS EVIDENT, TREAT THE BOTTLES AS POSITIVE AND DO NOT PLACE IN THE BACT/ALERT MICROBIAL DETECTION SYSTEM FOR MONITORING. OPTIMAL RECOVERY OF ISOLATES WILL BE ACHIEVED BY ADDING MAXIMUM AMOUNTS OF SPECIMEN. USE OF LOWER VOLUMES MAY ADVERSELY AFFECT RECOVERY AND/OR DETECTION TIMES OF SOME ORGANISMS. DO NOT FILL ABOVE THE BOTTLE'S MAXIMUM SPECIMEN VOLUME OF 10ML. THE VACUUM IN THE BOTTLE WILL USUALLY EXCEED 10 ML; MONITOR THE VOLUME COLLECTED BY MEANS OF THE 5 ML INCREMENTAL MARKINGS ON THE BOTTLE LABEL. LABORATORY PROCEDURE: VISUALLY INSPECT BOTTLES BEFORE TESTING. DO NOT USE BOTTLES WITH EVIDENCE OF DAMAGE, LEAKAGE, OR DETERIORATION. CONSIDER BOTTLES WITH HEMOLYSIS, TURBIDITY, EXCESS GAS PRESSURE, YELLOW SENSORS, AND/OR EVIDENCE OF GROWTH.
A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH BACT/ALERT® FA PLUS CULTURE BOTTLE (REFERENCE 410851). THE CUSTOMER REPORTED HAVING A FALSE NEGATIVE BOTTLE AFTER TEN (10) DAYS, BUT THE SENSOR ON THE BOTTLE OF THE BOTTLE WAS YELLOW. AFTER GRAM STAINING THE RESULT SHOWED A YEAST FUNGUS IN THE BLOOD SAMPLE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 792809 | BACT/ALERT® FA PLUS CULTURE BOTTLE | BACT/ALERT® FA PLUS CULTURE BOTTLE | MDB | BIOMERIEUX INC. | 4050853 | 03573026357900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |