BACT/ALERT I NST 100 BTLS - 259785
Report
- Report Number
- 3002769706-2024-00005
- Event Type
- Malfunction
- Date Received
- March 4, 2024
- Report Date
- August 29, 2024
- Manufacturer
- BIOMÉRIEUX INC.
- Product Code
- MDB
- PMA / PMN Number
- K021123
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF FALSE NEGATIVE RESULTS FOR A BLOOD AND STEM CELL SAMPLE WHILE TESTING THE SAMPLE WITH THE BACT/ALERT I NST (REF 259785, LOT 0001060240). ---INVESTIGATION--- COMPLAINT TREND ANALYSIS: GLOBAL CUSTOMER SERVICE (GCS) PERFORMED A COMPLAINT TREND ANALYSIS AND DID NOT IDENTIFY THE CUSTOMER'S ISSUE AS A TREND FOR THE BACT/ALERT I NST BOTTLES. MANUFACTURING RECORD REVIEW: GCS REVIEWED THE BATCH RECORDS FROM 0001060240 FOR ANY ABNORMALITIES IN THE PRODUCTION, FILLING, AUTOCLAVING, OR PACKAGING THAT MAY HAVE POTENTIALLY LED TO A FALSE NEGATIVE RESULT WHEN THE BOTTLE WAS INOCULATED. THE BATCH RECORDS DID NOT HAVE ANY UNUSUAL INCIDENTS REPORTED DURING THE MANUFACTURING STEPS, AND ALL ACCEPTABLE QUALITY LIMITS (AQL) CHECKS WERE COMPLETED WITHOUT ANY NON-CONFORMANCES. THE MICROBIOLOGY TESTING OF THE LOT CONFIRMED THE LOT GREW THE TARGET ANAEROBIC MICROORGANISMS WITHIN THE EXPECTED TIME. THERE ARE ALSO NO NON-CONFORMANCES OR QUALITY EVENTS FOR THIS LOT APPEARING IN OUR QUALITY MANAGEMENT SYSTEMS. THE RELEASE TESTING FOR THE LOT ALSO MET THE ACCEPTANCE CRITERIA. ANALYSIS OF CUSTOMER DATA: THE INITIAL DETAILS COLLECTED FROM THE CUSTOMER INDICATED THAT UPON GRAM STAINING THE BOTTLE, THERE WAS THE PRESENCE OF A GRAM-POSITIVE ORGANISM IN THE BOTTLE, HOWEVER, THE BOTTLE FAILED TO RESULT AS POSITIVE AFTER 14 DAYS OF INCUBATION ON THE BACT/ALERT® 3D INSTRUMENT. THE CUSTOMER INDICATED THAT NO FURTHER SUBCULTURING STEPS WERE PERFORMED AT THIS POINT, AS THE CUSTOMER LEFT THE BOTTLE ON THE TABLE AT ROOM TEMPERATURE OUT OF THE INCUBATOR FOR OVER 24 HOURS. THE LOCAL CUSTOMER SERVICE (LCS) TEAM PROCEEDED WITH GATHERING IMAGES OF THE IMPACTED BOTTLE AND THE GRAPH FROM THE BACT/ALERT® 3D. THE BACT/ALERT® 3D BACKUP DATA WAS ALSO REQUESTED TO BE ANALYZED BY GLOBAL INDUSTRY CUSTOMER SERVICE (GICS). THE BACT/ALERT® 3D BACKUP DATA WAS OBTAINED AND PROVIDED TO GICS ON 28FEB2024. THE CUSTOMER INDICATED BOTTLE ID ST16N2H4 WAS THE BOTTLE IMPLICATED IN THE FALSE NEGATIVE RESULT. THE BACKUP REVIEW WAS PERFORMED BY GICS ON 29FEB2024. THIS BACKUP REVIEW WAS ABLE TO CONFIRM THE CUSTOMERS REPORT THAT BOTTLE ID ST16N2H4 DID INDEED RESULT AS NEGATIVE ON THE BACT/ALERT 3D AFTER 14 DAYS OF INCUBATION. THE BOTTLE WAS FOUND TO BE LOADED ONTO THE INSTRUMENT ON 23JAN2024 AT 13:24:31 LOCAL TIME, INTO CELL 3D04 AND SET FOR A MAXIMUM INCUBATION OF 14 DAYS. THE BOTTLE RESULTS AS NEGATIVE BY HOW DETERMINED CODE 4 (MAXIMUM TEST TIME REACHED) ON 06FEB2024 AT 13:32:25 LOCAL TIME, AND THE BOTTLE WAS SUBSEQUENTLY REMOVED FROM THE INSTRUMENT ON 06FEB2024 AT 16:29:37 LOCAL TIME. THE REVIEW OF THE DATABASE BACKUP DID NOT REVEAL ANY ABNORMALITIES, OR USER INTERVENTION ON THE BOTTLE DURING ITS INCUBATION. THE BOTTLE DID REMAIN IN CELL 3D04 FOR THE COMPLETE DURATION OF THE TEST. GICS DETERMINED THE IAST CULTURE MEDIA BOTTLE BOTTLE ID SIHN3F0X WAS THE IMPLICATED BOTTLE¿S MATE AEROBIC BOTTLE, BASED ON THE ACCESSION ID¿S LINKING THESE TWO BOTTLES IN THE DATABASE BACKUP. GICS REVIEWED THE IAST BOTTLE HISTORY IN THE DATABASE BACKUP AS WELL AND WAS NOT ABLE TO DETERMINE ANY ABNORMALITIES OR USER INTERVENTIONS ON THIS BOTTLE RECORD EITHER. GICS EXTRACTED THE BOTTLE READINGS FOR BOTH THE IAST AND IMPLICATED INST BOTTLES FROM THE CUSTOMERS DATABASE BACKUP, TO BE ABLE TO RERUN THE BOTTLE DATA THROUGH THE GCS ALGORITHM TOOL. RERUNNING THE DATA THROUGH THIS TOOL CONFIRMED THE RESULTS OBTAINED BY THE CUSTOMER ON THE BACT/ALERT 3D, BY PROVIDING THE SAME RESULT OUTPUT (NEGATIVE) AND SIMILARLY SHAPED GRAPHS. FURTHER ANALYSIS OF THE BOTTLE RECORDS INDICATE THAT THE BOTTLES WERE TESTED AS EXPECTED ON THE BACT/ALERT 3D. THE BIOMATH TEAM ANALYZED THE CUSTOMER DATA BY RERUNNING THE REFLECTANCE DATA WITH THE ALGOTOOL AND WAS ABLE TO DETERMINE THAT BOTH THE INST BOTTLE ID ST16N2H4 (IMPLICATED FALSE NEGATIVE BOTTLE) AND THE MATE IAST AEROBIC BOTTLE ID SIHN3F0X BOTH RESULTED AS NEGATIVE. BIOMATH DETERMINED THAT THE REFLECTANCE CURVE FOR THE IAST BOTTLE WAS NEGATIVE, HOWEVER THE ST16N2H4 INST BOTTLE WAS QUESTIONABLE, AS THE CUSTOMER SUSPECTED THE PRESENCE OF AN ORGANISM IN THE BOTTLE. THE GROWTH OF THE ORGANISM IS EITHER VERY SLOW OR THE ORGANISM PRODUCES VERY LITTLE CO2. THE ALGOTOOL OUTPUT INDICATES THAT THE ALGORITHM FOR BOTTLE ID ST16N2H4 WAS NOT CLOSE TO DETERMINING THIS BOTTLE AS POSITIVE. FURTHER DISCUSSION WITH BIOMATH REVEALED THAT SINCE THE CUSTOMER¿S BOTTLE WAS TESTED USING THE INDUSTRY OPTIMIZED ALGORITHM FOR SLOW GROWTH ORGANISMS (ALGORITHM 19), THE PRODUCTION OF THE CO2 BY THE PRESUMPTIVE ORGANISM IN THE BOTTLE IS SO LOW, THAT THE ALGORITHM COULD HAVE MISTAKEN THE PRESENCE OF THE ORGANISM AS BACKGROUND NOISE, OR PASSIVE CELLULAR RESPIRATION. WHILE THE ALGORITHM IS OPTIMIZED TO DETECT SLOW GROWTH ORGANISMS, THE DEVELOPMENT OF THE ALGORITHM DOES REQUIRE A BALANCE BETWEEN DETERMINING THE PRESENCE OF EUKARYOTIC CELLULAR RESPIRATION (COMMON IN CLINICAL SAMPLES, AND CELL AND GENE-THERAPY PRODUCTS) AND THE DETECTION OF A SLOW GROWTH ORGANISM. HOWEVER, SINCE THE CUSTOMER WAS UNSUCCESSFUL AT PERFORMING THE SUBCULTURE FROM THE BOTTLE TO DETERMINE THE PRESENCE OF AN ORGANISM, IT IS UNKNOWN IF SUCH A STRAIN DID EXIST IN THE BOTTLE AS IT MAY HAVE NO LONGER BEEN VIABLE AT THE TIME OF SUBCULTURE. RETAIN SAMPLE REVIEW: NO RETAINS WERE EXAMINED SINCE THE COMPLAINT IS NOT RELATED TO A VISUAL DEFECT. REVIEW OF INSTRUCTIONS FOR USE: THE INSTRUCTIONS FOR USE (IFU) FOR THE INST BOTTLE TYPE AS WELL AS THE BACT/ALERT® 3D USER MANUAL PROVIDE ADEQUATE DIRECTIONS TO INSTRUCT THE USER HOW TO MANAGE BOTTLES THAT ARE SUSPECTED OF BEING POSITIVE ON THE BACT/ALERT® SYSTEM. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. THE INVESTIGATION DETERMINED THAT EITHER THERE WAS NO ORGANISM PRESENT IN THE INST BOTTLE, OR THERE WAS A FASTIDIOUS ORGANISM PRESENT THAT DID NOT PRODUCE ENOUGH CO2 TO TRIGGER A POSITIVE RESULT AND THE ORGANISM IS DIFFICULT TO ISOLATE ON CULTURE MEDIA. ---CONCLUSION--- THERE IS NO EVIDENCE OF ANY BOTTLE MALFUNCTION OF THE BACT/ALERT® INST CULTURE BOTTLES FROM LOT NUMBER 0001060240. THE LOT NUMBER MET ALL QUALITY RELEASE CRITERIA, AND THERE WERE NO MANUFACTURING ABNORMALITIES PRESENT IN THE BATCH RECORDS. ADDITIONALLY, TRENDING OF THE BOTTLE TYPE AND LOT NUMBERS DID NOT DETERMINE A TREND FOR FALSE NEGATIVE RESULTS WAS PRESENT FOR THIS LOT NUMBER. THE BACT/ALERT® 3D BACKUP FILES COLLECTED FROM THE CUSTOMER¿S SYSTEM DID NOT SHOW ANY LOSS OF CONTROL DURING THE INCUBATION PERIOD OF THE FALSE NEGATIVE BOTTLE. NO ERROR MESSAGES OR ALARMS APPEAR IN THE BACKUP THAT WOULD ACCOUNT FOR THE FALSE NEGATIVE EVENT, THEREFORE THE BACT/ALERT® SYSTEM WAS OPERATING WITHIN A STATE OF CONTROL. NO ROOT CAUSE COULD BE ATTRIBUTED TO THE PERFORMANCE OF THE BACT/ALERT® 3D SYSTEM. ADVICE AND RECOMMENDATIONS FOR LCS/CUSTOMER BASED ON IFU/INSTRUMENT MANUAL/TESTING: THE INSTRUCTIONS FOR USE (IFU) FOR THE INST BOTTLE TYPE AS WELL AS THE BACT/ALERT® 3D USER MANUAL PROVIDES ADEQUATE DIRECTIONS TO INFORM THE USER REGARDING HOW TO MANAGE BOTTLES THAT ARE SUSPECTED OF BEING POSITIVE ON THE BACT/ALERT® SYSTEM. PLEASE REFER TO THE RECOMMENDATIONS AND BEST PRACTICES BELOW BASED ON THE RESOURCES AND RESULTS FROM THIS INVESTIGATION: - PERFORM A SMEAR AND SUBCULTURE FROM ALL BOTTLES THAT RESULT POSITIVE OR APPEAR TO CONTAIN POSITIVE FEATURES UPON UNLOADING FINAL NEGATIVE BOTTLES. THESE FEATURES MAY INCLUDE SIGNS OF GAS PRODUCTION (BULGING SEPTUM), TURBID MEDIA, OR SENSOR COLOR CHANGE. SUBCULTURE METHODS SHOULD BE FOLLOWED TO ALIGN WITH THE MEDIA TYPE USED FOR TESTING. O ANAEROBIC (INST) BOTTLES SHOULD BE SUBCULTURED TO MEDIA SUITABLE FOR CULTIVATING FASTIDIOUS ANEROBIC ORGANISMS AND INCUBATED IN ANAEROBIC AND AEROBIC ATMOSPHERIC CONDITIONS TO DETECT ALL POTENTIAL CONTAMINATIONS WITHIN THE CULTURE MEDIA. O AEROBIC BOTTLES (IAST) SHOULD BE SUBCULTURED TO SUITABLE CULTURE MEDIA FOR CULTIVATION OF AEROBIC ORGANISMS AND INCUBATED IN AEROBIC ATMOSPHERIC CONDITIONS. - GRAM-STAINS PERFORMED FROM THE CULTURE MEDIA SHOULD BE PERFORMED CAREFULLY, AND MORPHOLOGICAL DISTINCTIONS SHOULD ATTEMPT TO BE MADE TO AID IN THE DETERMINATION REGARDING SUITABLE SUBCULTURE METHODS. - BOTTLES UNABLE TO BE SUBCULTURED IMMEDIATELY SHOULD BE STORED IN REFRIGERATED TEMPERATURES TO PROLONG THE VIABILITY STATE OF THE ORGANISM, UNTIL THE BOTTLE MAY BE SUBCULTURED FOR CONFIRMATION PURPOSES.
INTENDED USE: BACT/ALERT® I NST CULTURE BOTTLES ARE USED WITH THE BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR ENHANCED RECOVERY AND DETECTION OF A VARIETY OF ANAEROBIC AND FACULTATIVE MICROORGANISMS. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED FALSE NEGATIVE RESULTS FOR A BLOOD AND STEM CELL SAMPLE WHILE TESTING THE SAMPLE WITH THE BACT/ALERT I NST (REF (B)(4), LOT 0001060240). THE CUSTOMER REPORTED THAT WHEN THE BOTTLE WAS UNLOADED ON DAY 14, THEY NOTICED THAT THE INDICATOR ON THE BOTTOM OF THE BOTTLE WAS DISCOLORED AND THE MEDIA APPEARED VERY TURBID. THE MATE BOTTLE DID NOT SHOW ANY SIGNS OF ORGANISM GROWTH. AT THE TIME OF THIS ASSESSMENT, NO SUBCULTURE RESULTS HAVE BEEN PROVIDED. THE CELLS INOCULATED IN THE BOTTLES WERE TRANSPLANTED BACK INTO THE PATIENT, HOWEVER, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT. AN INVESTIGATION HAS BEEN INITIATED. NOTE: BACT/ALERT I NST (REF 259785) IS NOT AN IVD PRODUCT, HOWEVER, THERE IS AN IVD PRODUCT THAT IS EQUIVALENT TO THIS PRODUCT. BACT/ALERT SN (PLASTIC) 100 BTLS (REF (B)(4), K021123) IS THE CLINICAL EQUIVALENT TO THE I NST BOTTLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193906 | BACT/ALERT I NST 100 BTLS - 259785 | BACT/ALERT I NST 100 BTLS - 259785 | MDB | BIOMÉRIEUX INC. | 0001060240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |