BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL
Report
- Report Number
- 3002773840-2024-00366
- Event Type
- Malfunction
- Date Received
- August 8, 2024
- Date of Event
- June 18, 2024
- Report Date
- September 6, 2024
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Product Code
- PAM
- UDI-DI
- 00815381020338
- PMA / PMN Number
- K193519
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
SUMMARY: A POTENTIAL FALSE NEGATIVE ENTEROCOCCUS FAECALIS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL OCCURRED ON JUNE 18, 2024, AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. NO SERIOUS INJURY OR DEATH WAS REPORTED. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME. INVESTIGATION: ON JUNE 18, 2024, A POSITIVE BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED ALL ANALYTES AS NOT DETECTED. BIOFIRE'S INVESTIGATION INTO THIS EVENT IS ONGOING AND FURTHER INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FSCA HAS BEEN DEEMED NECESSARY AT THIS TIME. CONCLUSION: INVESTIGATION ONGOING.
INVESTIGATION: THE PATIENT WAS A 59-YEAR-OLD MALE WITH UNKNOWN CLINICAL SIGNS/SYMPTOMS AT THE TIME OF TESTING. ON JUNE 18, 2024, A POSITIVE BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE BCID2 PANEL LESS THAN ONE HOUR AFTER SIGNALING POSITIVE. THE BIOFIRE BCID2 PANEL REPORTED ALL ANALYTES AS NOT DETECTED. GRAM-POSITIVE COCCI IN CHAINS WERE OBSERVED ON GRAM STAIN. E. FAECALIS WAS RECOVERED FROM CULTURE AND IDENTIFIED VIA VITEK® MS (MALDI-TOF). ON JUNE 20, 2024, THE POSITIVE BLOOD CULTURE SAMPLE WAS RETESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED E. FAECALIS AS DETECTED. THE CUSTOMER REPORTED IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. THE FINAL DIAGNOSIS OF THE PATIENT IS UNKNOWN. NO SERIOUS INJURY OR DEATH WAS REPORTED. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 38KD24 (KIT LOT# 0439224) AND FILMARRAY TORCH INSTRUMENT (TM13694) WERE REVIEWED. THE POUCH LOT AND INSTRUMENT PASSED QC CRITERIA AND WERE FOUND WITHIN SPECIFICATIONS. IN-HOUSE INVESTIGATION: FILMARRAY TORCH INSTRUMENT (SERIAL NUMBER # (B)(6)) THAT WAS USED FOR THE BIOFIRE BCID2 PANEL TEST WAS RETURNED FOR A WORK ORDER TO ENSURE THAT THE INSTRUMENT WAS NOT CONTRIBUTING TO THE FALSE NEGATIVE RESULT OBSERVED AT THE CUSTOMER SITE. UPON COMPLETION OF THE WORK ORDER, THERE WAS NO EVIDENCE TO SUGGEST THAT THE FALSE NEGATIVE RESULT WAS CAUSED BY THE FILMARRAY TORCH INSTRUMENT (SERIAL NUMBER # (B)(6)). CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE FALSE NEGATIVE E. FAECALIS RESULT WAS DUE TO A BIOFIRE BCID2 PANEL POUCH ANOMALY. BIOFIRE IS CONTINUOUSLY MONITORING THE MANUFACTURING PROCESS AND HAS CONTROLS IN PLACE TO ENSURE PRODUCT IS MANUFACTURED TO THE HIGHEST QUALITY. EACH BIOFIRE REAGENT LOT IS QUALIFIED PRIOR TO PRODUCT RELEASE; THIS QUALIFICATION INCLUDES A HIGH STATISTICAL-CONFIDENCE SAMPLING TO CONFIRM THAT THE KIT COMPONENTS RELEASED FOR CUSTOMER USE ARE CONFORMING. ALL QUALITY CONTROL (QC) METRICS FOR THE POUCH LOT AND INSTRUMENT WERE MET, AND THEY PASSED QC. REVIEW OF THE ASSOCIATED INSTRUMENT SHOWED THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATION AND WERE NOT EXPECTED TO HAVE CONTRIBUTED TO THE DISCREPANCIES OBSERVED BY THE CUSTOMER. OVERALL, THE BIOFIRE BCID2 PANEL E. FAECALIS ASSAY HAS A FALSE NEGATIVE RATE OF <0.001 IN THE FIELD OVER THE LAST YEAR. THESE RATES ARE WITHIN BIOFIRE SYSTEM SPECIFICATIONS. ACCORDING TO TABLE 27. BIOFIRE BCID2 PANEL CLINICAL PERFORMANCE SUMMARY, ENTEROCOCCUS SPP. OF THE BIOFIRE BCID2 PANEL INSTRUCTIONS FOR USE (IFU) (WWW.ONLINE-IFU.COM/ITI0048), THE PERFORMANCE CLAIM FOR E. FAECALIS COMPARED TO STANDARD MANUAL AND AUTOMATED MICROBIOLOGICAL/BIOCHEMICAL IDENTIFICATION METHODS SHOWED AN OVERALL SENSITIVITY OF 95.3% (95% CI 84.5-98.7%) AND AN OVERALL SPECIFICITY OF 99.9% (95% CI 99.6-100%). ARCHIVED TESTING WAS NOT PERFORMED FOR E. FAECALIS OR E. FAECIUM. E. FAECALIS WAS DETECTED IN BOTH FALSE NEGATIVE SPECIMENS USING AN ADDITIONAL MOLECULAR METHOD. THE SINGLE FALSE POSITIVE SPECIMEN WAS NEGATIVE FOR E. FAECALIS WHEN TESTED WITH ADDITIONAL MOLECULAR METHODS.
SUMMARY: A POTENTIAL FALSE NEGATIVE ENTEROCOCCUS FAECALIS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL OCCURRED ON JUNE 18, 2024, AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. NO SERIOUS INJURY OR DEATH WAS REPORTED. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.
SUMMARY: A POTENTIAL FALSE NEGATIVE ENTEROCOCCUS FAECALIS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL OCCURRED ON (B)(6) 2024, AFTER TESTING A PATIENT'S POSITIVE BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THE BIOFIRE BCID2 PANEL RESULT. NO SERIOUS INJURY OR DEATH WAS REPORTED. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE FALSE NEGATIVE E. FAECALIS RESULT WAS DUE TO A BIOFIRE BCID2 PANEL POUCH ANOMALY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1675114 | BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL | BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL | PAM | BIOFIRE DIAGNOSTICS, LLC | RFIT-ASY-0147 | 0439224 | 00815381020338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male |