BACT/ALERT BPN
Report
- Report Number
- 3002769706-2022-00044
- Event Type
- Malfunction
- Date Received
- September 24, 2022
- Report Date
- June 21, 2023
- Manufacturer
- BIOMÉRIEUX, INC
- Product Code
- MZC
- PMA / PMN Number
- BK050043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF OBTAINING FALSE POSITIVE RESULTS FOR TWO BLOOD CULTURE BOTTLES ASSOCIATED WITH THE SAME DONOR (1 PERSON) WHILE TESTING THE SAMPLES WITH BACT/ALERT BPN EU (REF (B)(4), LOT 0001058837). ---INVESTIGATION--- COMPLAINT TREND ANALYSIS: QUERIES ON COMPLAINT DATA SHOWED NO ADVERSE TREND IS PRESENT FOR FALSE POSITIVE RESULTS USING RAUC ALGORITHM FOR INDUSTRY BLOOD CULTURE BOTTLES. NO OTHER FALSE POSITIVE COMPLAINTS WERE RECEIVED FOR THE BPN LOT 0001058837 (EXPIRED ON 18MAY2023). MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESSES ARE CAPTURED IN PROCEDURAL DIRECTIONS ON A ROUTINE BASIS AND RESULTS OF THESE DIRECTIONS ARE DOCUMENTED AS PART OF GOOD MANUFACTURING PRACTICES. MONITORING AND DETECTION METHODS RELATING TO POTENTIAL FALSE POSITIVE RESULTS ARE APPROPRIATELY IN PLACE AT THE DURHAM MANUFACTURING SITE. THE PACKAGING AQL INSPECTION RECORD AND THE FINAL AQL VISUAL INSPECTION SUMMARY AND DISPOSITION RECORD ARE IN PLACE TO IDENTIFY BOTTLE DEFECTS RELATING TO POTENTIAL FALSE POSITIVE RESULTS ASSOCIATED WITH MANUFACTURING PROCESSES OF BACT/ALERT® CULTURE BOTTLES. BATCH RECORD REVIEW OF BACT/ALERT ® BPN BOTTLE LOT 0001058837 SHOWED NO ABNORMALITIES THAT COULD ACCOUNT FOR THE FALSE-POSITIVE RESULT AT A CUSTOMER SITE. THE IFU FOR THE BACT/ALERT® BPN ALONG WITH THE BACT/ALERT® VIRTUO USER MANUAL PROVIDE ADEQUATE GUIDANCE ON HOW TO REDUCE THE CHANCES OF A USER OBTAINING FALSE POSITIVE RESULTS. MANUFACTURING EQUIPMENT IS MAINTAINED FOR OPERATION AND PROCEDURES ARE IN PLACE TO ADDRESS CALIBRATION AND RECOVERY DUE TO MALFUNCTIONS. ENVIRONMENTAL MONITORING OCCURS ON A ROUTINE BASIS IN THE MANUFACTURING FACILITY FOR BACT/ALERT® CULTURE BOTTLES. RETAINS: NO REQUIREMENT FOR TESTING OF RETAINED CULTURE BOTTLES FOR BACT/ALERT® BPN LOT 0001058837. FALSE POSITIVE RESULTS OCCURRED WITH INOCULATED CULTURE BOTTLES. CONCLUDE PRODUCT COMPLIANCE TO SPECIFICATION/PERFORMANCE: THERE IS NO EVIDENCE OF ANY BOTTLE MALFUNCTION WITH THE BACT/ALERT® BPN CULTURE BOTTLE LOT 0001058837. MONITORING AND DETECTION METHODS FOR BOTTLE DEFECTS ASSOCIATED WITH POTENTIAL FALSE POSITIVE RESULTS ARE PART OF THE MANUFACTURING AND QUALITY CONTROL PROCESSES FOR BACT/ALERT® CULTURE BOTTLES. FALSE POSITIVES CAN BE MINIMIZED BY FOLLOWING THE BEST PRACTICES, SEE ADVICE BELOW. ROOT CAUSE: BASED ON THE EVALUATION OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, THE INVESTIGATION WAS NOT ABLE TO DETERMINE DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S TWO FALSE POSITIVE RESULTS WITH BPN BOTTLE WHEN TESTING ONE DONOR SAMPLE OF PLATELET. THE ROOT CAUSE ANALYSIS COULD NOT REJECT THE HYPOTHESIS OF SAMPLE RELATED FALSE POSITIVE RESULTS, AS CUSTOMER CLAIMED TO NOT RECOVER ANY MICROORGANISM IN THE SUBCULTURE. IN ADDITION, BOTH SAMPLES COME FROM THE SAME DONOR, AND AS THE CUSTOMER'S FALSE POSITIVE RATE IS VERY LOW, ROOT CAUSE SEEMS RELATED TO SAMPLE ITSELF. THERE WERE NO INSTRUMENT ALARMS USER HANDLING OF THE BOTTLES AT THE TIME TO POSITIVE. THE CUSTOMER DID NOT REPORT ANY VISUAL DEFECTS WITH THE BOTTLES. ---CONCLUSION--- THE INVESTIGATION COULD NOT DETERMINE THE CAUSE FOR THE CUSTOMER'S FALSE POSITIVE RESULTS. HOWEVER, THE INVESTIGATION DID NOT DETERMINE THIS ISSUE TO BE A SYSTEMIC PRODUCT PERFORMANCE PROBLEM FOR THE BACT/ALERT BPN EU (REF (B)(4)). ADVICE AND RECOMMENDATIONS FOR LCS/CUSTOMER BASED ON IFU/INSTRUMENT MANUAL/TESTING: THE INVESTIGATOR REVIEWED THE INSTRUCTIONS FOR USE [IFU] AND BACT/ALERT® VIRTUO USER MANUAL WHICH PROVIDES ADEQUATE DIRECTIONS TO REDUCE THE CHANCES OF OBTAINING FALSE POSITIVE RESULTS WITH BACT/ALERT® BOTTLES: -INSPECT BOTTLES BEFORE USE, AND DO NOT USE ANY THAT APPEAR DAMAGED OR CONTAMINATED -FAILURE TO ACHIEVE ADEQUATE LEUKOCYTE REDUCTION MAY RESULT IN FALSE POSITIVE READINGS PER THE IFU LIMITATIONS OF TEST -ENSURE THE TEMPERATURE WHERE THE INSTRUMENT IS LOCATED FLUCTUATES AT A MINIMUM (E.G. INSTRUMENT IS AWAY FROM DIRECT VENTS, WINDOW DRAFTS) -THE VIRTUO® INSTRUMENT AUTOMATICALLY LOADS UP TO 40 BOTTLES THAT ARE PLACED IN THE LOADING AREA AT ONE TIME. DO NOT OVERLOAD THE CONVEYOR BELT -IF BANK CAPACITY IS FULL, BOTTLES ON THE CONVEYOR CANNOT BE LOADED INTO THE INSTRUMENT, USER IS INSTRUCTED TO UNLOAD BOTTLES WITH FINAL NEGATIVE OR POSITIVE STATUS -WASTE CONTAINER IS NEARING CAPACITY, ALREADY FULL, OR MISSING: NEGATIVE BOTTLES CANNOT UNLOAD FROM INSTRUMENT -ALL INSTRUMENT POSITIVES MUST BE UNLOADED AND A GRAM STAIN AND SUBCULTURE PERFORMED. IF THE GRAM STAIN SHOWS NO ORGANISMS THE BOTTLE CAN BE RELOADED TO COMPLETE ITS INCUBATION TIME. -SINCE THE TWO POSITIVE BOTTLES WERE BOTH ANAEROBIC BOTTLES, IT IS RECOMMENDED TO PERFORM A GRAM STAIN AND USE BOTH AEROBIC AND ANAEROBIC AGAR PLATES INCUBATED IN BOTH AEROBIC AND ANAEROBIC ATMOSPHERES FOR THE SUBCULTURE.
INTENDED USE: BACT/ALERT® BPN CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS (BACT/ALERT® 3D AND BACT/ALERT® VIRTUO®) FOR QUALITY CONTROL TESTING OF LEUKOCYTE-REDUCED APHERESIS PLATELET (LRAP) UNITS, BOTH SINGLE AND POOLS OF UP TO SIX (6) UNITS OF LEUKOCYTE-REDUCED WHOLE BLOOD PLATELET CONCENTRATES (LRWBPC), AND POOLS OF UP TO FOUR (4) UNITS OF LEUKOCYTE-REDUCED WHOLE BLOOD DERIVED BUFFY COAT PLATELETS (LRWBDBCP). BACT/ALERT® BPN CULTURE BOTTLES SUPPORT THE GROWTH OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA). DESCRIPTION: A CUSTOMER IN AUSTRALIA NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE RESULTS FOR TWO BLOOD CULTURE BOTTLES ASSOCIATED WITH THE SAME DONOR (1 PERSON) WHILE TESTING THE SAMPLES WITH BACT/ALERT BPN EU (REF 279045, LOT 0001058837). THE CUSTOMER REPORTED THAT TWO BOTTLES (PNVNKX68 AND PNVNKX6S) FLAGGED AS POSITIVE DURING INCUBATION, BUT GRAM STAINING AND SUBCULTURES WERE NEGATIVE FOR BOTH BOTTLES. NO TEMPERATURE-RELATED OR POWER-RELATED ALARMS OCCURRED FOR THE DATE RANGE ASSOCIATED WITH EITHER BOTTLE. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO A DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR ANY PATIENT. THE BACT/ALERT BPN EU (REF. (B)(4) ARE INDUSTRY ONLY PRODUCTS AND ARE NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, THE BACT/ALERT SN (REF. (B)(4) IS AN EQUIVALENT PRODUCT THAT IS INTENDED FOR CLINICAL (IVD) USE AND APPROVED FOR USE IN THE UNITED STATES. INDUSTRY BACT/ALERT® BOTTLES CONTAIN THE SAME CULTURE MEDIUM FORMULATION AND ARE MANUFACTURED IN THE SAME LOT AS CLINICAL BACT/ALERT® CULTURE BOTTLES. AN INVESTIGATION WILL BE INITIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1435920 | BACT/ALERT BPN | BACT/ALERT BPN | MZC | BIOMÉRIEUX, INC | 0001058837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |