CONTROL MODULE PKGD 3D - 210147
Report
- Report Number
- 1950204-2022-00028
- Event Type
- Malfunction
- Date Received
- October 7, 2022
- Report Date
- March 13, 2024
- Manufacturer
- BIOMÉRIEUX, INC.
- Product Code
- MDB
- UDI-DI
- 03573026049522
- PMA / PMN Number
- K981736
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE MDR GUIDANCE, "MEDICAL DEVICE REPORTING FOR MANUFACTURERS, ISSUED NOVEMBER 8, 2016", SECTION 2.15, ESTABLISHES THAT ONCE A MALFUNCTION HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY, A PRESUMPTION THAT THE MALFUNCTION IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY HAS BEEN ESTABLISHED. BIOMÉRIEUX HAS PERFORMED A REVIEW AND ANALYSIS OF THE MDR SUBMISSIONS, SPECIFIC TO THE BIOMÉRIEUX BACT/ALERT® REAGENTS AND VIRTUO® INSTRUMENT. THE REVIEW INCLUDED MDRS SUBMITTED TO THE FDA FROM 01-JAN-2022 TO 22-FEB-2024. BASED UPON OUR REVIEW AND ANALYSIS OF BIOMÉRIEUX BACT/ALERT® REAGENTS AND VIRTUO® INSTRUMENT MDR SUBMISSIONS, THERE HAVE BEEN NO CUSTOMER CLAIMS OF DEATH OR SERIOUS INJURY IN THE PAST TWO (2) YEARS. EACH HAS BEEN INVESTIGATED OR IS CURRENTLY UNDERGOING INVESTIGATION, AND ANY ISSUES HAVE BEEN ADDRESSED BY THE MANUFACTURING SITE. WITH THE COMPLETION OF OUR MDR DATA ANALYSIS, WE HAVE UPDATED OUR MDR CRITERIA FOR BACT/ALERT® REAGENTS AND VIRTUO® INSTRUMENT. MALFUNCTION EVENTS FOR MEDICAL DEVICE PROBLEM CODE: A2303, IMPROPER OR INCORRECT PROCEDURE OR METHOD WILL NO LONGER BE REPORTED FOR ALL BACT/ALERT® REAGENTS AND VIRTUO® INSTRUMENT (PRODUCT CODES: MDB, MZC) AS THESE EVENTS ARE NOT "LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY" IF THEY WERE TO RECUR. MOVING FORWARD, IF WE BECOME AWARE OF A DEATH OR SERIOUS INJURY EVENT RELATED TO NONSTANDARD DEVICE RESULTS OBTAINED WITH AN BACT/ALERT® REAGENTS OR VIRTUO® INSTRUMENT, WE WILL REPORT THAT EVENT TO THE FDA PER THE FDA MDR GUIDANCE AND UPDATE OUR MDR CRITERIA TO INCLUDE REPORTING THE SPECIFIC ASSOCIATED MALFUNCTION AS REQUIRED BY THE MDR GUIDANCE.
AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF OBTAINING FALSE NEGATIVE RESULTS FOR MULTIPLE BACT/ALERT® BOTTLES (FN PLUS AND FA PLUS) IN ASSOCIATION WITH THE CONTROL MODULE PKGD 3D (REF 210147, SERIAL: (B)(6). INVESTIGATION: CONTEXT: COMPLAINT INVESTIGATION (B)(4) WAS INITIATED ON COMPLAINT CONTACT DATE 09SEP2022 IN RESPONSE TO ONE COMPLAINT RELATING TO FALSE NEGATIVE AEROBIC AND ANAEROBIC BLOOD CULTURES RANDOMLY OCCURRING IN THREE BACT/ALERT® 3D INCUBATION MODULES. THE CUSTOMER INSTRUMENT IS A BACT/ALERT® 3D VERSION B.50 SYSTEM WITH CONTROL MODULE SERIAL NUMBER: (B)(6) INSTALLED IN DECEMBER 2018. THREE INCUBATION MODULES (IM) WITH SERIAL NUMBERS: (B)(6), ARE CONNECTED TO THIS CONTROL MODULE. BOTTLE TYPES BACT/ALERT® FA PLUS AEROBIC (PART: 410851) AND FN PLUS ANAEROBIC (PART: 410852) CULTURE BOTTLES ARE IN USE. A LIST OF THIRTEEN (13) BOTTLE IDS WITH MULTIPLE LOT NUMBERS WAS PROVIDED ON 06OCT2022. BOTTLE GRAPHS AND PICTURES WERE ALSO PROVIDED FOR SEVEN (7) BOTTLE IDS. AN INSTRUMENT BACKUP WAS PROVIDED FOR THE INVESTIGATION ON 07OCT2022. THE COMPLAINT (B)(4) IS FROM A CLINICAL DIAGNOSTIC HOSPITAL CUSTOMER LOCATED IN (B)(6). A FURTHER PART 3 INVESTIGATION WAS INITIATED ON 12OCT2022. NO OTHER COMPLAINTS ARE REFERENCED TO THIS INVESTIGATION. IMPACT: THE IMPACT TO PATIENT IS UNKNOWN AS THE CUSTOMER DID NOT SHARE ANY INFORMATION IN THE COMPLAINT CASE. A DELAY IN REPORTING A POSITIVE BLOOD CULTURE COULD CONTRIBUTE TO IMPROPER TREATMENT OF THE PATIENT THAT LEADS TO HARM. THE IMPACT TO THE CUSTOMER IS THAT INSTRUMENT FALSE NEGATIVES COULD IMPACT THE PATIENT¿S HEALTH AND IMPROPER HANDLING OF BOTTLES THAT FLAG POSITIVE BY THE INSTRUMENT INDICATES IMPROPER TRAINING OF THE LABORATORY STAFF. THE IMPACT TO BUSINESS IS THAT A FALSE NEGATIVE RESULT COULD LEAD TO A NEGATIVE IMPACT FOR A PATIENT. THE RISK ASSESSMENT DETERMINED THE RISK TO PATIENT WAS LOW. IMMEDIATE ACTION DONE BY LCS AND OR WORKAROUND. THE IMMEDIATE ACTION BY THE CUSTOMER WAS TO CONTACT BIOMÉRIEUX LEVEL 1 LOCAL CUSTOMER SERVICE (LCS) ON (B)(6) 2022 TO REPORT A RANDOM OCCURRENCE OF FALSE NEGATIVE BOTTLES ASSOCIATED WITH THEIR B.50 BACT/ALERT 3D SYSTEM AFTER THEY NOTICED THAT FINAL NEGATIVE BOTTLES HAD YELLOW SENSORS AND THEY PERFORMED GRAM STAINS AND SUBCULTURES THAT SHOWED POSITIVE RESULTS. THE IMMEDIATE ACTION BY LCS WAS TO DISPATCH A FIELD SERVICE ENGINEER (FSE) TO EVALUATE THE INSTRUMENT AND THE ISSUE AT THE CUSTOMER SITE. THE IMMEDIATE ACTION BY LCS WAS TO DISPATCH A FIELD SERVICE ENGINEER (FSE) TO EVALUATE THE INSTRUMENT AND THE ISSUE AT THE CUSTOMER SITE. NO ISSUES WERE FOUND, FSE REQUESTED CASE BE ESCALATED AND TO KEEP SITE UNDER OBSERVATION. A FOLLOW-UP WAS PERFORMED ON (B)(6) 2022, AND THE ISSUE WAS STILL OCCURRING, SO DATA WAS COLLECTED (BOTTLE IDS, BOTTLE GRAPHS) AND AN INSTRUMENT BACKUP WAS OBTAINED. THE COMPLAINT WAS ESCALATED TO LEVEL 2 GLOBAL CUSTOMER SERVICE (GCS) FOR ASSISTANCE ON (B)(6) 2022. THE COMPLAINT WAS FIRST DISCUSSED WITH THE BACT/ALERT CROSS FUNCTIONAL TEAM ON 05OCT2022. INVESTIGATION AND TREND REVIEW: THE INVESTIGATION INVOLVED PERFORMING AN ANALYSIS OF THE INSTRUMENT BACKUP AND BOTTLE RECORDS PROVIDED. THE INVESTIGATOR REVIEWED THE INSTRUCTIONS FOR USE, THE COMPLAINT DATABASE, AND THE MANUFACTURING DATABASE. NO ADVERSE TRENDS WERE IDENTIFIED IN THE MANUFACTURING DATABASE OR COMPLAINT DATABASE RELATED TO THIS ISSUE AND THE BACT/ALERT 3D INSTRUMENT. INSTRUCTIONS FOR USE REVIEW: THE BACT/ALERT® 3D B.50 USER MANUAL 514818-1EN1 2015-12 ¿ EN WAS REVIEWED BY THE INVESTIGATOR. PAGE 5.31 STATES: RELOADING POSITIVE BOTTLES SMEAR AND SUBCULTURE ALL BOTTLES DETERMINED POSITIVE BY THE SYSTEM. IF A POSITIVE BOTTLE IS RELOADED WITHIN 10 MINUTES OF BEING UNLOADED, THE BOTTLE STATUS REMAINS POSITIVE AND THE STATUS DETERMINATION CODE IS 250. IF THE BOTTLE IS RELOADED MORE THAN 10 MINUTES AFTER BEING UNLOADED, THE STATUS REVERTS TO NEGATIVE-TO-DATE. THE SYSTEM ALGORITHMS ARE LOOKING FOR THE ORGANISM¿S LOG PHASE GROWTH CURVE. IF A POSITIVE BOTTLE IS RELOADED AT THE END OF, OR AFTER, THE LOG PHASE GROWTH CURVE, THE BOTTLE MAY OR MAY NOT BE FLAGGED POSITIVE AGAIN. THEREFORE, TRUE POSITIVE BOTTLES THAT ARE RELOADED MAY OR MAY NOT FLAG POSITIVE ON THE SYSTEM AGAIN. THE SUBCULTURE MADE AT THE INITIAL POSITIVE FLAG SHOULD BE RELIED UPON FOR THE CULTURE RESULTS. CAUTION: FAILURE TO PERFORM A SMEAR AND SUBCULTURE AFTER IDENTIFYING A POSITIVE ANONYMOUS BOTTLE, OR BEFORE RELOADING A POSITIVE BOTTLE, MAY LEAD TO A FALSE NEGATIVE RESULT. CAUTION: A POSITIVE BOTTLE THAT IS RELOADED INTO THE INSTRUMENT AFTER 10 MINUTES AUTOMATICALLY REVERTS TO A NEGATIVE-TO-DATE STATUS. TRUE POSITIVE BOTTLES THAT ARE RELOADED MAY NOT FLAG POSITIVE AGAIN, DUE TO A LACK OF CONTINUED CO2 PRODUCTION BY THE MICROORGANISM AND/OR INSUFFICIENT INCUBATION TIME REMAINING FOR THE BOTTLE. IF A POSITIVE ANONYMOUS BOTTLE IS IDENTIFIED AND RELOADED IT MUST BE DONE SO USING A ONE BOTTLE AT A TIME APPROACH IN ORDER FOR IT TO REMAIN IN A POSITIVE STATUS BEFORE IT IS GRAM STAINED AND SUBCULTURED. IN EVERY OTHER SITUATION IT IS IMPERATIVE THAT ALL BOTTLES SIGNALED POSITIVE BY THE INSTRUMENT BE GRAM STAINED AND SUBCULTURED BEFORE THEY ARE RELOADED INTO THE SYSTEM. FAILURE TO COMPLY WITH THIS RECOMMENDATION MAY LEAD TO A FALSE NEGATIVE RESULT. CAUTION: BOTTLE READINGS ARE NOT PROCESSED FOR BOTTLES THAT ARE FORCED POSITIVE BY THE INSTRUMENT. THE INVESTIGATOR REVIEWED THE BACT/ALERT® FA PLUS CULTURE BOTTLE INSTRUCTIONS FOR USE (IFU), PART: 410851, DOCUMENT: (B)(4). SEE THE FOLLOWING PERTINENT EXCERPTS. THE BACT/ALERT® FA PLUS CULTURE BOTTLE TEST PROCEDURE SECTION HAS THE FOLLOW DIRECTIONS THAT STATE: THESE BOTTLES SHOULD BE UTILIZED BY TRAINED HEALTHCARE PERSONNEL. AFTER CULTURE BOTTLES HAVE BEEN LOADED INTO THE INSTRUMENT, INCUBATE 5 DAYS OR UNTIL DESIGNATED POSITIVE. SMEAR AND SUBCULTURE ALL POSITIVE BOTTLES. IF THE SMEAR IS NEGATIVE, INDICATING A POSSIBLE FALSE POSITIVE, THE BOTTLE SHOULD BE RELOADED INTO THE INSTRUMENT UNTIL GROWTH OF THE SUBCULTURE OR REDESIGNATION AS POSITIVE. BOTTLES THAT WERE INITIALLY DETERMINED FALSE POSITIVE AND WERE REDESIGNATED POSITIVE SHOULD BE SMEARED AND SUBCULTURED. NEGATIVE CULTURES MAY BE CHECKED BY SMEAR AND/OR SUBCULTURE AT SOME POINT PRIOR TO DISCARDING AS NEGATIVE. PROCEDURES FOR LOADING AND UNLOADING CULTURE BOTTLES INTO THE APPROPRIATE BACT/ALERT® INSTRUMENT ARE GIVEN IN THE USER MANUAL. RESULTS: POSITIVE OR NEGATIVE CULTURE BOTTLES ARE DETERMINED BY DECISION-MAKING SOFTWARE CONTAINED IN THE BACT/ALERT® MICROBIAL DETECTION SYSTEMS. NO ACTION IS REQUIRED UNTIL THE BACT/ALERT® INSTRUMENT SIGNALS CULTURE BOTTLES POSITIVE OR 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. PROMPTLY REMOVE POSITIVE CULTURE BOTTLES WHEN THEY ARE SIGNALED BY BACT/ALERT® TO AVOID POSSIBLE NON-VIABLE CULTURES DUE TO AUTOLYSIS OR OTHER REASONS. CERTAIN STRAINS OF STREPTOCOCCUS PNEUMONIAE MAY BE PARTICULARLY PRONE TO AUTOLYSIS IF THEY ARE NOT REMOVED PROMPTLY AFTER BEING SIGNALED POSITIVE. THE INVESTIGATOR CONCLUDES THAT THE IFU PROVIDE ADEQUATE DIRECTIONS FOR THE USER. ROOT CAUSE ANALYSIS AND CONCLUSION: THE ROOT CAUSE FOR THE INCIDENT WAS OPERATOR ERROR. THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE TO PERFORM GRAM STAIN AND SUBCULTURE ON BOTTLES FLAGGED POSITIVE BY THE INSTRUMENT. THE ANALYSIS OF THE BACKUP SHOWED THAT ALL BOTTLES WERE FLAGGED POSITIVE BY THE INSTRUMENT, BUT THE CUSTOMER LATER RELOADED THEM WITHOUT PERFORMING THE GRAM STAIN AND SUBCULTURE. THE GAPS IN TIME FROM UNLOADING TO RELOADING RANGED FROM ABOUT AN HOUR TO FIVE HOURS. THERE WAS NO MALFUNCTION OF THE BACT/ALERT 3D INSTRUMENT OR CULTURE BOTTLES. REQUESTED ACTION FOR LOCAL CUSTOMER SERVICE: PLEASE PROVIDE RETRAINING TO CUSTOMER STAFF THAT ARE ASSIGNED TO PERFORM BLOOD CULTURE TESTING WITH THE BACT/ALERT 3D SYSTEM. PLEASE FOCUS ON POSITIVE BOTTLE HANDLING TO ENSURE THAT BOTTLES ARE TESTED AND HANDLED CORRECTLY. DOCUMENT OFFER TO RETRAIN IN THE COMPLAINT CASE COMMENTS. PLEASE REVIEW IFU WITH CUSTOMER, SEE EXCERPTS ABOVE.
INTENDED USE: THE BACT/ALERT® 3D MICROBIAL DETECTION SYSTEM IS AN AUTOMATED TEST SYSTEM CAPABLE OF INCUBATING, AGITATING, AND CONTINUOUSLY MONITORING AEROBIC AND ANAEROBIC MEDIA INOCULATED WITH PATIENT SPECIMENS SUSPECTED OF HAVING BACTEREMIA, FUNGEMIA, AND/OR MYCOBACTEREMIA. DESCRIPTION: A CUSTOMER IN INDIA NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS FOR MULTIPLE BACT/ALERT® BOTTLES (FN PLUS AND FA PLUS) IN ASSOCIATION WITH THE CONTROL MODULE PKGD 3D (REF 210147, SERIAL (B)(4). THE CUSTOMER PROVIDED DETAILS FOR 13 BOTTLES FOR WHICH THE SENSORS HAD TURNED YELLOW (INDICATING A POSITIVE BOTTLE), BUT THE INSTRUMENT DID NOT FLAG THE BOTTLES AS POSITIVE. GRAM STAINING RESULTS WERE PROVIDED FOR 11 BOTTLES, AND IDENTIFICATIONS OF RECOVERED ORGANISMS WERE PROVIDED FOR 9 BOTTLES. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE FALSE NEGATIVE RESULTS HAVE LED TO OR CONTRIBUTED TO A DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR ANY PATIENT. AN INVESTIGATION WILL BE INITIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2554746 | CONTROL MODULE PKGD 3D - 210147 | CONTROL MODULE PKGD 3D - 210147 | MDB | BIOMÉRIEUX, INC. | 210147 | 03573026049522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |