INCUBATOR MOD LEFT W/RACKS 3D
Report
- Report Number
- 1950204-2021-00081
- Event Type
- Malfunction
- Date Received
- November 11, 2021
- Report Date
- May 10, 2022
- Manufacturer
- BIOMÉRIEUX, INC.
- Product Code
- MDB
- UDI-DI
- 03573026049577
- PMA / PMN Number
- K903505
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING A NOTIFICATION FROM A CUSTOMER IN THE UNITED STATES THAT THEY'VE OBSERVED AN INCREASE IN FALSE POSITIVE RESULTS WHILE TESTING BLOOD PLATELET SAMPLES IN ASSOCIATION WITH THEIR BACT/ALERT® INCUBATOR MOD LEFT W/RACKS 3D (REF 210159, SERIAL (B)(6)). THE FALSE POSITIVE RATE IS UNDER 1% OF ALL BOTTLES LOADED (NUMBER OF FALSE POSITIVE BOTTLES/TOTAL NUMBER OF BOTTLES LOADED X 100 = FALSE POSITIVE RATE%). THERE IS NO IMPACT TO A PATIENT BECAUSE THE PLATELET BOTTLES INVOLVED IN THE COMPLAINT UNDER INVESTIGATION WERE INSTRUMENT FALSE POSITIVES WHERE NO ORGANISM IS PRESENT. INVESTIGATION. THE INVESTIGATION DID NOT FIND ANY MALFUNCTION FOR THE BACT/ALERT SYSTEM. WHILE THE CUSTOMER NOTED THE FALSE POSITIVE RATE INCREASED, IT IS STILL LOW AT UNDER 1% OF ALL BOTTLES TESTED. THE BOTTLE INSTRUCTIONS FOR USE (IFU) AND BACT/ALERT 3D USER MANUAL BOTH DISCUSS FALSE POSITIVES WITH THIS TECHNOLOGY. EVALUATION OF THE INSTRUMENT DATA BACKUPS REVEALED THE MOST LIKELY ROOT CAUSE OF THE FALSE POSITIVES WAS TEMPERATURE CHANGES IN THE RACK ASSOCIATED WITH LOADING OR UNLOADING BOTTLES INTO/FROM RACKS WHERE BOTTLES WERE ALREADY UNDER TEST. THIS TEMPERATURE CHANGE CAUSES A SHIFT IN THE BOTTLE READINGS FOR THE BOTTLES ALREADY UNDER TEST, THAT THE ALGORITHM MAY INTERPRET AS A POSITIVE. THE INVESTIGATOR STATED THE MAJORITY OF THE FALSE POSITIVE GRAPHS REVIEWED DISPLAYED SHIFTS (DIPS OR INCREASES IN BOTTLE READINGS). THE SHIFTS CORRESPOND TO PRIOR COLD (ROOM TEMPERATURE) BOTTLE LOADING EVENTS IN THE RACK / DRAWER (S) BEFORE THE BOTTLES ARE CALLED POSITIVE. THESE SHIFTS ALSO OCCUR SOMETIMES DURING AN UNLOAD EVENT. THIS IS THE MOST LIKELY ROOT CAUSE. THE BACT/ALERT 3D DOES HAVE A COLD BOTTLE COMPENSATION FILTER (CBCF) BUILT IN TO HELP REDUCE THE MAGNITUDE OF THE IMPACT ON THE BOTTLE READINGS WHEN A NEW ROOM TEMPERATURE BOTTLE IS LOADED IN A RACK WHERE A BOTTLE IS UNDER TEST. THIS FEATURE DOES NOT TOTALLY PREVENT THIS TYPE OF FALSE POSITIVE BUT IT DOES REDUCE THE OCCURRENCE. FOR RACKS AND INCUBATION MODULES BUILT AFTER JUNE 2012, THE FEATURE IS PRESENT IN THE RACK FIRMWARE AUTOMATICALLY AND IT DOES NOT NEED TO BE ENABLED. FOR RACKS AND INCUBATION MODULES BUILT BEFORE THIS DATE, THE VERSION B.50 FIRMWARE ON THE CONTROL MODULE HAS A CONFIGURATION FEATURE THAT CAN BE ENABLED (FOR CUSTOMERS WITH A FALSE POSITIVE ISSUE RELATED TO LOADING PATTERNS IN OLDER SYSTEMS). ENABLING THIS FEATURE IN NEWER SYSTEMS DOES NOT IMPACT TESTING AS IT IS IGNORED. THE RACK HARDWARE VERSIONS WERE REVIEWED FOR THE CUSTOMER¿S INSTRUMENT, AND TWO INCUBATION MODULES HAVE OLDER RACK VERSIONS THAT REQUIRE THE CBCF TO BE ENABLED IN THE B.50 CONTROL MODULE FIRMWARE. LEVEL 2 GLOBAL CUSTOMER SERVICE (GCS) ASKED LEVEL 1 LOCAL CUSTOMER SERVICE (LCS) TO ENABLE THE CBCF. THE USER MANUAL 514818-1EN1 2015-12 ¿ EN BACTALERT 3D B.50 WAS REVIEWED BY THE INVESTIGATOR. THE BASIC FUNCTIONS SECTION GIVES A CAUTION IN THE LOADING AND UNLOADING BOTTLES SECTIONS THAT STATES: IF A LARGE NUMBER OF BOTTLES ARE LOADED INTO/UNLOADED FROM THE INCUBATION MODULE AT THE SAME TIME AND IN THE SAME AREAS, A LARGE HEAT MASS LOSS WITHIN THE RACKS MAY OCCUR. THIS HEAT LOSS MAY TRIGGER THE ACCELERATION OR RATE ALGORITHMS TO ERRONEOUSLY FLAG POSITIVE. THE STEPS ALSO STATE TO LIMIT THE BOTTLE LOAD/UNLOAD TIME TO NO MORE THAN 2 MINUTES IN ONE AREA. CLOSE THE DRAWER TO ALLOW TEMPERATURE TO EQUILIBRATE BEFORE LOADING/UNLOADING FROM THE AREA AGAIN. SEE BEST PRACTICES IN APPENDIX C FOR PREVENTING FALSE POSITIVES. THE INSTRUMENT WILL ALARM WITH FAULT CODE 20 IF THE DRAWER IS OPEN LONGER THAN 2 MINUTES, CLOSING THE DRAWER WILL CLEAR THE ERROR. HANDLING UNCONFIRMED POSITIVE BOTTLES (FALSE POSITIVES) SECTION STATES IF THE SMEAR OF A POSITIVE BOTTLE REVEALS NO MICROORGANISMS, THE BOTTLE SHOULD BE SUB-CULTURED AND RELOADED INTO THE INSTRUMENT. THE INVESTIGATION REVIEWED THE PLATELET BOTTLE INSTRUCTIONS FOR USE (IFU) BACT/ALERT® BPA PART 423278 DOCUMENT 052232- 03 - 2020-08 AND BACT/ALERT® BPN PART 423279 DOCUMENT 052233- 03 - 2020-08. THE LABORATORY PROCEDURE STATES THAT ALL POSITIVE BOTTLES SHOULD BE SMEARED AND SUB-CULTURED. IF THE SMEAR IS NEGATIVE, INDICATING A POSSIBLE FALSE POSITIVE, THE BOTTLE SHOULD BE RELOADED INTO THE INSTRUMENT UNTIL GROWTH OF SUBCULTURE OR RE-DESIGNATION AS POSITIVE. CULTURES WHICH WERE INITIALLY DETERMINED FALSE POSITIVE AND WERE RE-DESIGNATED POSITIVE SHOULD BE SMEARED AND SUB-CULTURED. THE LIMITATIONS OF THE TEST STATES: MANY VARIABLES INVOLVED IN PLATELET 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. 1. A GRAM-STAINED SMEAR FROM A NEGATIVE BOTTLE MAY SOMETIMES CONTAIN A SMALL NUMBER OF NON-VIABLE ORGANISMS THAT WERE DERIVED FROM CULTURE MEDIUM COMPONENTS, STAINING REAGENTS, IMMERSION OIL, OR GLASS SLIDES, THEREFORE, FALSE-POSITIVE RESULTS ARE INDICATED. 2. FALSE POSITIVE READINGS CAN OCCUR DUE TO NOISE ON THE POWERLINE, PLACING THE INSTRUMENT IN DIRECT SUNLIGHT, OR WITH DRAMATIC TEMPERATURE FLUCTUATIONS. 3. FAILURE TO ACHIEVE ADEQUATE LEUKOCYTE REDUCTION MAY RESULT IN FALSE POSITIVE READINGS. DATA TABLES IN THE PERFORMANCE CHARACTERISTICS SECTION OF THE IFU DESCRIBE A LOW FALSE POSITIVE RATE OF 0.25%. THE SPECIFICITY & SENSITIVITY SECTION STATES¿ ¿A TOTAL OF 106 INSTRUMENT FALSE POSITIVE RESULTS WERE OBSERVED FOR AN OVERALL FALSE POSITIVE RATE OF 0.3%. THE INDIVIDUAL STUDIES REPORTED 0%, 0.11% AND 1.1% INSTRUMENT FP¿. THE INVESTIGATOR CONCLUDES THAT THE IFU PROVIDE ADEQUATE DIRECTIONS FOR THE USER. THE CUSTOMER SHOULD FOLLOW THE DIRECTIONS IN THE BOTTLE¿S INSTRUCTIONS FOR USE TO PERFORM A GRAM STAIN AND SUBCULTURE ON ALL BOTTLES DESIGNATED POSITIVE. - COMPLAINT ANALYSIS. QUERIES OF THE MANUFACTURING DATA, AND THE COMPLAINT DATA DO NOT REVEAL THIS TO BE A SYSTEMIC QUALITY PROBLEM. - CONCLUSION. A SINGLE ROOT CAUSE FOR INCREASED FALSE POSITIVE RATE WAS NOT IDENTIFIED BUT THE MOST LIKELY THE FALSE POSITIVE RATE IS DUE TO BULK LOADING EVENTS. BOTH BACKUPS WERE REVIEWED AND IT SHOWS THE SITE DOES CONTINUE TO PERFORM BULK LOADING AND UNLOADING. THE USER MANUAL 514818-1EN1 APPENDIX C BEST PRACTICES STATES THE FOLLOWING ¿ IF LARGE NUMBER OF BOTTLES ARE LOADED INTO THE BACT/ALERT3D, OR UNLOADED FROM THE BACTALERT 3D AS THE SAME TIME AND IN THE SAME AREAS, THERE MAY BE A VERY LARGE HEAT LOSS WITHIN THE RACKS. THIS MAY TRIGGER THE ACCELERATION OR RATE ALGORITHMS TO ERRONEOUSLY FLAG POSITIVE. THE RECOMMENDATION IS FOR THE SITE TO MODIFY THE LOADING PATTERNS TO REDUCE THE OPPORTUNITY THAT COLD BOTTLE LOADS IMPACT THE CURRENTLY LOADED BOTTLES. THE DATA SHOWS THAT LARGE BOTTLE LOADS CAN IMPACT CURRENT BOTTLES LOADED, TRIGGERING THEM AS POSITIVE BUT WHEN SUBCULTURED THE BOTTLES ARE FALSE. BIOMÉRIEUX RECOMMENDS THE CUSTOMER CHANGE THE LOADING PATTERNS TO HELP REDUCE THE FALSE POSITIVES. ANOTHER POTENTIAL ROOT CAUSE IS THE CBCF WAS DISABLED AND WHEN COLD (ROOM TEMPERATURE) BOTTLES ARE LOADED THEY ARE IMPACTING THE CURRENTLY LOADED BOTTLES IN THE RACK. INCUBATION MODULES (312IL4371 (IM1), 910IR7590 (IM2)) INSTALLED AT THE SITE REQUIRE THE CBCF TO BE ENABLED. THE MAJORITY OF THE FALSE POSITIVES ARE OCCURRING IN THESE TWO INCUBATION MODULES WHICH HAVE THE OLDER STYLE RACKS THAT NEED TO HAVE CBCF ENABLED. BIOMÉRIEUX RECOMMENDS THE SITE ENABLE THE CBCF FEATURE IN THE B.50 CONTROL MODULE FIRMWARE USING THE BTA 3D SETUP AND CONFIGURATION 514483-8EN1 DOCUMENT AS THE FIRST MEASURE OF TROUBLESHOOTING AGAINST FALSE POSITIVES. IF THE CUSTOMER CONTINUES TO HAVE ISSUES, FOLLOW THE BEST PRACTICES WHEN LOADING AND UNLOADING BOTTLES. OLDER RACKS HAVE HW REV 147-1B AND SW REV 1.13, AND NEW RACKS HAVE HW REV 147-1H SW REV 2.02 ON THE INCUBATION MODULE INFORMATION SCREEN.
A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN INCREASE IN FALSE POSITIVE RESULTS WHILE TESTING BLOOD PLATELET SAMPLES IN ASSOCIATION WITH THEIR BACT/ALERT® INCUBATOR MOD LEFT W/RACKS 3D (REF 210159, SERIAL (B)(4)). THE CUSTOMER CLAIMED THAT THEY HAVE EXPERIENCED A 500% INCREASE IN FALSE POSITIVE RESULTS. OF THIRTY-SIX (36) POSITIVE BOTTLES THE CUSTOMER WAS TRACKING, SEVEN (7) WERE CONFIRMED TO BE TRUE POSITIVES. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER FOR TROUBLESHOOTING PURPOSES. AT THE TIME OF THIS ASSESSMENT, NO ADDITIONAL INFORMATION OF BACKUP FILES HAVE BEEN RECEIVED FROM THE CUSTOMER. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INVESTIGATION WILL BE INITIATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1691664 | INCUBATOR MOD LEFT W/RACKS 3D | INCUBATOR MOD LEFT W/RACKS 3D | MDB | BIOMÉRIEUX, INC. | 210159 | 03573026049577 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |