BACT/ALERT FA PLUS (PLASTIC)®
Report
- Report Number
- 3002769706-2023-00021
- Event Type
- Malfunction
- Date Received
- September 15, 2023
- Date of Event
- September 4, 2023
- Report Date
- November 20, 2023
- Manufacturer
- BIOMERIEUX INC.
- Product Code
- MDB
- UDI-DI
- 03573026357900
- PMA / PMN Number
- K121461
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CONTEXT: ********** A CUSTOMER IN GERMANY NOTIFIED BIOMÉRIEUX OF OBTAINING TWO FALSE NEGATIVE RESULTS WHEN USING THE BACT/ALERT FA PLUS - 410851 ( LOT#0004101624 - EXPIRATION DATE : 13 MARCH 2024). INDEED, THE CUSTOMER INDICATED HAVING FOUND TWO POSITIVE BOTTLES IN THE TRASH OF THE VIRTUO. THESE BOTTLES HAVE NOT BEEN FLAGGED BY THE INSTRUMENT AS POSITIVE. THE SUBCULTURE OF THESE BOTTLES HAS SHOWN A MICROBIAL GROWTH. A VISUAL INSPECTION OF THE BOTTLES REVEALED YELLOW SENSORS, POTENTIAL POSITIVE RESULTS. TWO OTHER BOTTLES (AR5V3XLV AND NR31HXTH) TESTED FOR THE SAME PATIENT FLAGGED POSITIVE ON THE CUSTOMER¿S INSTRUMENT. THE BOTTLES WERE TESTED ON THE BACT/ALERT® VIRTUO® INSTRUMENT WITH A UNIT (PART 411660) SERIAL NUMBER (B)(6). THERE ARE TWO B UNITS (PART 411661) ON THIS BANK WITH SERIAL NUMBERS (B)(6). THIS SYSTEM WAS INSTALLED ON 13APR2023 AND HAS SOFTWARE VERSION 03.01.01.1274 (3.0) AND IS CONNECTED TO A MYLA® SERVER. THE ORGANISM IDENTIFIED IN THE TWO POSITIVE BOTTLES AND TWO FALSE NEGATIVE BOTTLES WAS ENTEROBACTER CLOACAE (E. CLOACAE). NO SPECIFIC HARM TO THE PATIENT IS STATED IN THE COMPLAINT, AND THE FACT THAT ONE BLOOD CULTURE SET DID FLAG POSITIVE AND WAS HANDLED APPROPRIATELY REDUCES THE IMPACT FOR THE PATIENT. INVESTIGATION RESULTS *********************** **REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER ** ¿ BOTTLES WERE NOT PRE-INCUBATED ¿ BACKUP OF THE VIRTUO INSTRUMENT WAS RECEIVED (B)(6) 2023 ¿ FA PLUS LOT 0004101488 EXPIRY DATE 14JAN2024 AND FN PLUS LOT 0004059750 EXPIRY DATE 21JAN2024 ¿ FN PLUS BOTTLE ID (B)(4)-FALSE NEGATIVE, FA PLUS BOTTLE ID AR590SVV-FALSE NEGATIVE ¿ TWO BOTTLES WERE TRUE POSITIVES: FA PLUS BOTTLE ID (B)(4), FN PLUS BOTTLE ID NR31HXTH ¿ ORGANISM IDENTIFICATION BY MALDI-TOF AND WAS ENTEROBACTER CLOACAE IN ALL FOUR BOTTLES ¿ GLOBAL CUSTOMER SERVICE (GCS) EVALUATED VIRTUO BACKUP DATA FOR THE FOUR (4) BOTTLE IDS AND CONFIRMED POSITIVE/NEGATIVE RESULTS FOR ALL BOTTLE BUT ONE (1(B)(4) (FN PLUS BOTTLE) ¿ SAMPLE VOLUME STATUS WAS DISABLED ON THE CUSTOMER¿S VIRTUO INSTRUMENT ¿ CUSTOMER REPORTED THAT ALL BOTTLES WERE VISUALLY INSPECTED PRIOR TO LOADING INTO THE INSTRUMENT ¿ BOTTLE ID (B)(4): RACK D/CELL 8, LOADED (B)(6) 2023, UNLOADED (B)(6) 2023 TO WASTE, RESULT=NEGATIVE ¿ BOTTLE ID (B)(4): RACK D/CELL 24, LOADED (B)(6)2023, UNLOADED (B)(6) 2023 TO WASTE, RESULT=NEGATIVE ¿ BOTTLE ID (B)(4) (POSSIBLE MATE BOTTLE): RACK I/CELL 4, LOADED (B)(6) 2023, UNLOADED (B)(6) 2023, RESULT=POSITIVE ¿ BOTTLE ID (B)(4) (POSSIBLE MATE BOTTLE): NO INSTRUMENT DATA AVAILABLE FOR THIS FN PLUS BOTTLE ¿ NO DRAW TIMES WERE AVAILABLE FOR ANY OF THE BOTTLES ¿ PATIENT SAMPLES WERE TAKEN IN THE HOSPITAL AND TESTED IN THE HOSPITAL LABORATORY. SAMPLES ARE COLLECTED 2-3 TIMES A DAY AND TAKEN TO THE LABORATORY FOR TESTING. TIME BETWEEN SAMPLING AND LOADING OF BOTTLES INTO THE VIRTUO INSTRUMENT WAS NINE (9) HOURS DATA FOR THE TWO (2) FALSE NEGATIVE BOTTLES WENT TO DATA SCIENCE FOR EVALUATION (TWO DIFFERENT SOFTWARE VERSIONS) WITH ALGOTOOL: VIRTUO 3.0 SOFTWARE VERSION: (B)(4)=NEGATIVE, (B)(4)=NEGATIVE AND (B)(4)=POSITIVE AT 24.88 HOURS VIRTUO 3.1 SOFTWARE VERSION: (B)(4)=POSITIVE AT 1.07 HOURS, (B)(4)=POSITIVE AT 1.14 HOURS AND (B)(4)=POSITIVE AT 24.88 HOURS. INITIAL REFLECTANCE VALUES WERE VERY HIGH (>43000) FOR BOTTLES (B)(4) INDICATING A POSSIBLE DELAYED ENTRY. **PRODUCTION RECORDS** ALL STATISTICAL IN PROCESS CONTROLS WERE MONITORED AND AQL INSPECTIONS (E.G., BOTTLE DEFECTS ASSOCIATED WITH POTENTIAL FALSE NEGATIVE RESULTS) WERE PERFORMED FOR BOTH LOTS AS PART OF ROUTINE BATCH RECORDS. ALL QUALITY CONTROL SPECIFICATIONS PASSED FOR RELEASE OF FA PLUS (LOT 0004101488) AND FN PLUS (LOT 0004059750) PRODUCTS TO CUSTOMERS. **COMPLAINT ANALYSIS** AN ANALYSIS HAS BEEN PERFORMED AGAINST FALSE POSITIVE RESULT AND DID NOT INDICATE ANY SYSTEMATIC QUALITY ISSUE. AN ANALYSIS HAS BEEN PERFORMED AGAINST FA PLUS LOT NUMBER 0004101488 AND DID NOT INDICATE ANY SYSTEMATIC QUALITY ISSUE. **DEVIATION/CAPA REVIEW** A ANALYSIS OF THE DEVIATION AND CAPA DATA HAS BEEN PERFORMED AND DID NOT INDICATE ANY CAPA OR DEVIATIONS RELATED TO THIS COMPLAINT. **ROOT CAUSE ANALYSIS** THE FISHBONE DIAGRAM (¿5M+E¿) METHOD OF ANALYSIS WAS USED TO INVESTIGATE AND IDENTIFY THE POTENTIAL ROOT CAUSE/ROOT CAUSE FOR THIS COMPLAINT. THIS CAUSE-AND-EFFECT ANALYSIS IDENTIFIES ASPECTS OF THE ISSUE IN RELATION TO FOLLOWING CONDITIONS: MEASUREMENT, MATERIALS, METHOD, MACHINE, MANPOWER, AND ENVIRONMENT. THE INVESTIGATOR REVIEWED MANUFACTURING PROCESSES FOR BACT/ALERT CULTURE BOTTLES THAT ADDRESS THE POTENTIAL BOTTLE DEFECTS ASSOCIATED WITH FALSE NEGATIVE RESULTS DURING PRODUCTION, AS WELL AS COMMUNICATION BETWEEN CUSTOMER SERVICE AND THE CUSTOMER PERTAINING TO THE COMPLAINT ISSUE AS PART OF THE EVALUATION FOR COMPLAINT. THE IS-IS NOT MATRIX WAS USED TO NARROW DOWN THE FACTORS AND VERIFY WHICH ONES POTENTIALLY CONTRIBUTE/CONTRIBUTE TO THIS COMPLAINT AND THOSE THAT DO NOT HAVE IMPACT OR CONTRIBUTE TO THIS COMPLAINT INVESTIGATION. THE ROOT CAUSE ASSESSMENT SHOWED THAT 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 NEGATIVE RESULTS DUE TO BOTTLE DEFECTS ARE APPROPRIATELY IN PLACE AT THE DURHAM MANUFACTURING SITE. THE IFUS FOR THE BACT/ALERT FA PLUS AND FN PLUS ALONG WITH THE VIRTUO USER MANUAL PROVIDE ADEQUATE GUIDANCE ON HOW TO REDUCE FALSE NEGATIVE RESULTS. MANUFACTURING EQUIPMENT IS MAINTAINED FOR OPERATION AND PROCEDURES ARE IN PLACE TO CONDUCT PRODUCTION PROCESSES. ENVIRONMENTAL MONITORING OCCURS ON A ROUTINE BASIS IN THE MANUFACTURING FACILITY FOR BACT/ALERT CULTURE BOTTLES. BASED ON THE EVALUATION OF DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER, THERE ARE THREE MOST PROBABLE ROOT CAUSES FOR FALSE NEGATIVE RESULTS WITH THE BACT/ALERT FA PLUS AND FN PLUS BOTTLES ASSOCIATED WITH COMPLAINT INV-16355: MEASUREMENT, MATERIALS, AND MANPOWER ARE THE POTENTIAL CONTRIBUTING FACTORS TO THE ROOT CAUSE OF THIS COMPLAINT. CONCLUSION: *********************** THERE IS NO EVIDENCE OF ANY BOTTLE MALFUNCTION WITH THE BACT/ALERT FA PLUS OR FN PLUS CULTURE BOTTLE LOTS. GROWTH OF E. CLOACAE OCCURRED IN ALL FOUR BOTTLES WITH THE SAME SAMPLES FROM THE SAME PATIENT; HOWEVER, DELAY IN LOADING THE BOTTLES INTO THE INSTRUMENT AFTER THE COLLECTION OF PATIENT SAMPLES CONTRIBUTED TO THE INCREASED GROWTH OF THE ORGANISM AND PAST THE POINT OF DETECTION BY THE BOTTLE ALGORITHMS.
INTENDED USE. BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION OF THE ISSUE. A CUSTOMER IN GERMANY NOTIFIED BIOMÉRIEUX OF OBTAINING TWO FALSE NEGATIVE RESULTS WHEN USING THE BACT/ALERT FA PLUS - 410851 ( LOT#0004101624 - EXPIRATION DATE : 13 MARCH 2024). INDEED, THE CUSTOMER INDICATED HAVING FOUND TWO POSITIVE BOTTLES IN THE TRASH OF THE VIRTUO. THESE BOTTLES HAVE NOT BEEN FLAGGED BY THE INSTRUMENT AS POSITIVE. THE SUBCULTURE OF THESE BOTTLES HAS SHOWN A MICROBIAL GROWTH. THE CUSTOMER INDICATED THAT HE DID NOT PRE INCUBATE THESE BOTTLES. SUMMARY: FA PLUS - 410851 - LOT#0004101624. BOTTLE ID(S) : (B)(6) ¿ FALSE NEGATIVE. (B)(6) ¿ FALSE NEGATIVE. AT THE TIME OF THE ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR ANY PATIENT. THIS EVENT HAS BEEN REVIEWED FOR VIGILANCE REPORTING IN ACCORDANCE WITH 21 CFR 803, CONCERNING MEDICAL DEVICE REPORTING. PER BIOMÉRIEUX INTERNAL STANDARD OPERATING PROCEDURES, FALSE NEGATIVE RESULTS IN ASSOCIATION WITH BACT/ALERT IS CONSIDERED TO BE A POTENTIALLY REPORTABLE EVENT (PRE). IT COULD RESULT TO NEGATIVE INFLUENCE ON THE MEDICAL DIAGNOSIS WITH NO PERMANENT DETERIORATION ON THE PATIENT STATE OF HEALTH, BECAUSE OTHER DIAGNOSTIC INFORMATION IS AVAILABLE. INJURY OR ILLNESS COULD RESULT FROM THE LACK OF APPROPRIATE DIAGNOSIS OR THERAPY, OR RESULT FROM CONTINUED ADMINISTRATION OF INAPPROPRIATE ANTIMICROBIALS OR OTHER POTENTIALLY TOXIC THERAPIES, SINCE FAILURE TO ISOLATE THE CAUSATIVE AGENT PRECLUDES THE DETERMINATION OF THE INFECTING AGENT¿S IDENTIFICATION AND SUSCEPTIBILITY PROFILE. THEREFORE, THERAPY MAY NOT BE TAILORED APPROPRIATELY. IN ADDITION, THE PATIENT MAY BE SUBJECTED TO ADDITIONAL (UNNECESSARY) DIAGNOSTICS AS A CONSEQUENCE OF THIS HAZARD. MITIGATED BY THE FACT THAT INFECTIONS ARE DIAGNOSED BY OTHER CLINICAL AND LABORATORY CRITERIA AS WELL, AND THAT ANTIBIOTIC THERAPY IS OFTEN PRESCRIBED EMPIRICALLY, BASED ON THE CLINICAL FINDINGS ALONE. THIS REVIEW HAS DETERMINED THAT THIS EVENT MEETS THE CRITERIA FOR REPORTING AS A MALFUNCTION. ALTHOUGH THIS EVENT DOES NOT ALLEGE THAT DEATH OR SERIOUS INJURY ACTUALLY OCCURRED, IT HAS BEEN DETERMINED THAT THERE IS POTENTIAL FOR SERIOUS INJURY SHOULD THE SITUATION RECUR WHILE TESTING A PATIENT ISOLATE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328330 | BACT/ALERT FA PLUS (PLASTIC)® | BACT/ALERT FA PLUS (PLASTIC)® | MDB | BIOMERIEUX INC. | 0004101624 | 03573026357900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |