INCUBATOR MOD RGHT W/RACKS 3D

Report

Report Number: 1950204-2021-00079
Event Type: Malfunction
Date Received: October 14, 2021
Report Date: May 10, 2022
Manufacturer: BIOMÉRIEUX, INC.
Product Code: JTA
UDI-DI: 03573026049591
PMA / PMN Number: K903505
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING A NOTIFICATION FROM A CUSTOMER IN THE UNITED STATES THAT THEY OBSERVED AN INCREASED RATE OF FALSE POSITIVE CULTURE BOTTLE RESULTS IN ASSOCIATION WITH THE BACT/ALERT 3D SYSTEM (REF. 210161, SERIAL NUMBER (B)(6)). THE CUSTOMER PROVIDED SPREADSHEETS WITH LISTS OF BOTTLE INFORMATION, AND INSTRUMENT BACKUPS FOR THE INVESTIGATION. THE PLATELET CULTURE BOTTLES IN USE WERE BACT/ALERT® BPA US PART 423278 AND BACT/ALERT® BPN US PART 423279. THERE WAS NO PATTERN IDENTIFIED BY BOTTLE TYPE OR LOT NUMBER. 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. THE BLOOD BANK MUST NOTIFY THE HOSPITAL IF THE UNIT HAS BEEN DISPATCHED OR TRANSFUSED BEFORE THE GRAM STAIN AND SUBCULTURE RESULTS ARE KNOWN. 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 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, 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. WHILE THE CUSTOMER¿S LOADING AND UNLOADING PATTERNS DID ALIGN WITH BEST PRACTICES, THE FALSE POSITIVES ARE ASSOCIATED WITH THIS ROOT CAUSE ON EVALUATION OF THE BACKUP DATA. 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 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 ABOUT 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. 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. 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 SUBCULTURED 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 SUBCULTURED. IF THE SMEAR IS NEGATIVE, INDICATING A POSSIBLE FALSE POSITIVE, THE BOTTLE SHOULD BE RELOADED INTO THE INSTRUMENT UNTIL GROWTH OF SUBCULTURE OR REDESIGNATION AS POSITIVE. CULTURES WHICH WERE INITIALLY DETERMINED FALSE POSITIVE AND WERE REDESIGNATED POSITIVE SHOULD BE SMEARED AND SUBCULTURED. 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. 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 ANY SYSTEMIC QUALITY PROBLEMS. CONCLUSION. MULTIPLE INSTRUMENT DATA BACKUPS WERE REVIEWED TO DETERMINE THE CAUSE OF THE FALSE POSITIVES BY ACCELERATION ALGORITHM. THERE WERE NO TEMPERATURE, FAULT OR OPERATOR ERRORS THAT CAUSED THE BOTTLES TO GO POSITIVE. THE READINGS WERE EXTRACTED AND THE IN-HOUSE ALGORITHM TOOL FLAGGED ALL THE BOTTLES POSITIVE, WHICH INDICATES NO ISSUES WERE FOUND WITH THE ALGORITHM. BASED ON THE REFLECTANCE CURVES REVIEWED THE BOTTLES LOOK VISUALLY NEGATIVE. THE NEGATIVE-LOOKING CURVES ALL HAVE SHIFTS (DIPS OR INCREASES IN READINGS) PRIOR TO BEING FLAGGED POSITIVE. THESE DIPS OR INCREASES IN BOTTLE READINGS CORRESPOND TO BOTTLE LOAD OR UNLOAD EVENTS RECORDED PRIOR IN THE RACK OR DRAWER. SEE ATTACHMENT INV-8434 GRAPH EXAMPLE. THE ALGORITHM FLAGS A BOTTLE POSITIVE BY DETECTING CHANGES OF THE REFLECTANCE CURVE. IT IS MOST LIKELY THAT THESE SHIFTS CAUSED SUFFICIENT CHANGES IN THE CURVE TO TRIGGER THE POSITIVE CALL BY THE ALGORITHM. THE INSTRUMENT PERFORMED AS DESIGNED. TO HELP REDUCE THESE LOADS / UNLOADS EVENTS FROM IMPACTING CURRENTLY LOADED BOTTLES POTENTIALLY CAUSING FALSE POSITIVES IS TO TRY ONE OF THE FOLLOWING: - ADD AN ADDITIONAL INCUBATOR MODULE TO INCREASE CAPACITY TO REDUCE LOADING AND UNLOADING EVENTS THAT COULD IMPACT CURRENTLY LOADED BOTTLES. - ADJUST LOADING PATTERNS BY ONLY LOADING BOTTLES IN A RACK THEN ALLOWING THOSE BOTTLES TO FINISH TESTING BEFORE LOADING ADDITIONAL BOTTLES IN THAT RACK. - UPGRADE TO THE VIRTUO INSTRUMENTS. THIS RATE HAS INCREASED AT THE CUSTOMER SITE SINCE THEY HAVE IMPLEMENTED LARGE VOLUME DELAYED SAMPLING (LVDS) DUE TO THE NEW REGULATIONS, BUT THE OVERALL FALSE POSITIVE RATE AT THE SITE IS ESTIMATED AROUND 0.7%. THERE IS NO SUPPORTING EVIDENCE THAT THE FALSE POSITIVES ARE SAMPLE RELATED. THE INSTRUMENTS PERFORMED AS DESIGNED SO THE CUSTOMER WILL CONTINUE TO EXPERIENCE FALSE POSITIVES. MORE RECOMMENDATIONS ARE TO: AVOID LOADING AND UNLOADING BOTTLES IN LARGE BATCHES TO PREVENT IMPACT TO BOTTLE GRAPHS IN SAME LOCATION STILL UNDER TEST AVOID ERROR 20 DRAWER OPEN LONGER THAN TWO MINUTES MAINTAIN A STABLE ROOM TEMPERATURE WHERE INSTRUMENT IS LOCATED (PREVENT TEMPERATURE FLUCTUATIONS) TRY TO LOAD NO /OR ONE NEW BOTTLE IN AN INSTRUMENT RACK THAT ALREADY HAS BOTTLES UNDER TEST. BY ORGANIZING THE LOAD EVENTS EACH DAY TO AVOID RACKS WHERE BOTTLES ARE ALREADY TESTING, THE IMPACT OF TEMPERATURE CHANGE INSIDE THE INCUBATION MODULE CAN BE MINIMIZED. LOADING LARGE BATCHES OF BOTTLES AT THE SAME TIME INTO AN EMPTY INCUBATION MODULE IS OKAY SINCE THERE ARE NOT BOTTLES PRESENT THAT ARE UNDER TEST. THE INVESTIGATOR NOTED THE CUSTOMER'S WORKLOAD ON THE NEWER INSTRUMENT MORE THAN DOUBLED DURING THE LAST SIX MONTHS.

Description of Event or Problem · 0

INTENDED USE: THE BACT/ALERT® 3D LOW TEMPERATURE (LT) MODULE IS PART OF THE BACT/ALERT® 3D DUAL-T SYSTEM, WHICH IS AN AUTOMATED MICROBIAL DETECTION TEST SYSTEM CAPABLE OF INCUBATING, AGITATING, AND CONTINUOUSLY MONITORING AEROBIC AND ANAEROBIC CULTURE MEDIA. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® 3D DUAL-T SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. DESCRIPTION OF THE PROBLEM: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INCREASED RATE OF FALSE POSITIVE CULTURE BOTTLE RESULTS IN ASSOCIATION WITH THE BACT/ALERT 3D SYSTEM (REF. (B)(4), SERIAL NUMBER (B)(4)). THE CUSTOMER STATED THE FALSE POSITIVE RESULTS ARE NOT ISOLATED TO A SPECIFIC BOTTLE TYPE OR LOT. THE CUSTOMER INDICATED THEY ARE USING BPA AND BPN BOTTLES PREDOMINANTLY, FOR PLATELET SAMPLES. THE CUSTOMER CURRENTLY HAS ONLY ONE INCUBATOR MODULE AVAILABLE DUE TO A VALIDATION PROCESS, AND DID NOT HAVE THE COLD BOTTLE COMPENSATION FILTER ENABLED. THE HIGH VOLUME OF BOTTLE LOADING COUPLED WITH THE SINGLE INCUBATOR, AND NO COMPENSATION FILTER, IS A LIKELY CAUSE OF THE FALSE POSITIVE BOTTLE RESULTS. THE CUSTOMER INDICATED NO VISIBLE GROWTH IN THE BOTTLES, GRAM STAINS ARE NEGATIVE. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM OR TREATMENT DELAY CAUSED BY FALSE POSITIVE RESULTS. AN INVESTIGATION WILL BE INITIATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1533472	INCUBATOR MOD RGHT W/RACKS 3D	INCUBATOR MOD RGHT W/RACKS 3D	JTA	BIOMÉRIEUX, INC.	210161		03573026049591

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown