BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL
Report
- Report Number
- 3002773840-2024-00371
- Event Type
- Malfunction
- Date Received
- August 22, 2024
- Date of Event
- July 20, 2024
- Report Date
- October 18, 2024
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Product Code
- PAM
- UDI-DI
- 00815381020338
- PMA / PMN Number
- K193519
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION: ON (B)(6) 2024, A POSITIVE BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED ALL ANALYTES AS NOT DETECTED. THE PATIENT'S RESULTS WERE DELAYED DUE TO THE BIOFIRE BCID2 PANEL. NO SERIOUS INJURY OR DEATH WAS REPORTED. 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 75-YEAR-OLD MALE WHO PRESENTED WITH SIGNS/SYMPTOMS OF CENTRAL LINE INFECTION. ON (B)(6) 2024, A POSITIVE BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED ALL ANALYTES AS NOT DETECTED. ON THE SAME DAY, THE PATIENT'S POSITIVE BLOOD CULTURE SAMPLE WAS RETESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED S. AUREUS AS DETECTED. GRAM-POSITIVE COCCI IN CLUSTERS WERE OBSERVED ON GRAM STAIN AND S. AUREUS WAS RECOVERED FROM CULTURE. THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE BCID2 PANEL, THE PATIENT'S RESULTS WERE DELAYED BY APPROXIMATELY TWO AND HALF HOURS. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THIS DELAY. THE FINAL DIAGNOSIS OF THE PATIENT WAS SEPSIS DUE TO S. AUREUS. NO SERIOUS INJURY OR DEATH WAS REPORTED. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 3A4G24 (KIT LOT# 0715524) AND FILMARRAY TORCH INSTRUMENT (TM13758) WERE REVIEWED. THE POUCH LOT AND INSTRUMENT PASSED QC CRITERIA AND WERE FOUND WITHIN SPECIFICATIONS. IN-HOUSE INVESTIGATION: FILMARRAY TORCH INSTRUMENT (SERIAL NUMBER # TM13758) THAT WAS USED FOR THE INITIAL 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 # TM13758). CONCLUSION: THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE FALSE NEGATIVE S. AUREUS RESULT ON THE BIOFIRE BCID2 PANEL WAS A POUCH ANOMALY. BIOFIRE IS CONTINUOUSLY MONITORING THE MANUFACTURING PROCESS AND HAS CONTROLS IN PLACE TO ENSURE THE 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 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 WAS NOT EXPECTED TO HAVE CONTRIBUTED TO THE DISCREPANCIES OBSERVED BY THE CUSTOMER. OVERALL, S. AUREUS ON BIOFIRE BCID2 PANEL 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 29. BIOFIRE BCID2 PANEL CLINICAL PERFORMANCE SUMMARY, STAPHYLOCOCCUS SPP. OF THE BIOFIRE BCID2 INSTRUCTIONS FOR USE (WWW.ONLINE-IFU.COM/ITI0048), THE PERFORMANCE CLAIM FOR THE S. AUREUS ASSAY COMPARED TO STANDARD MANUAL AND AUTOMATED MICROBIOLOGICAL/BIOCHEMICAL IDENTIFICATION METHODS SHOWED AN OVERALL SENSITIVITY OF 100% (95% CI 97.6-100%) AND AN OVERALL SPECIFICITY OF 99.9% (95% CI 99.5-100%). S. AUREUS WAS DETECTED IN BOTH FALSE POSITIVE SPECIMENS USING AN ADDITIONAL MOLECULAR METHOD.
INVESTIGATION: ON (B)(6) 2024, A POSITIVE BLOOD CULTURE SAMPLE WAS TESTED ON THE BIOFIRE BCID2 PANEL. THE BIOFIRE BCID2 PANEL REPORTED ALL ANALYTES AS NOT DETECTED. THE PATIENT'S RESULTS WERE DELAYED DUE TO THE BIOFIRE BCID2 PANEL. NO SERIOUS INJURY OR DEATH WAS REPORTED. 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. UPDATE FOR FOLLOW-UP REPORT: BIOFIRE IS STILL INVESTIGATING THIS EVENT IN ORDER TO DETERMINE THE ROOT CAUSE. THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. CONCLUSION: INVESTIGATION ONGOING.
SUMMARY: A POTENTIAL FALSE NEGATIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL OCCURRED ON (B)(6) 2024, AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. DUE TO THE BIOFIRE BCID2 PANEL, THE PATIENT'S RESULTS WERE DELAYED. 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 STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL OCCURRED ON (B)(6) 2024, AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. DUE TO THE BIOFIRE BCID2 PANEL, THE PATIENT'S RESULTS WERE DELAYED BY APPROXIMATELY TWO AND A HALF HOURS. IT IS UNKNOWN IF THE PATIENT WAS IMPACTED DUE TO THIS DELAY. NO SERIOUS INJURY OR DEATH WAS REPORTED. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE FALSE NEGATIVE S. AUREUS RESULT ON THE BIOFIRE BCID2 PANEL WAS A POUCH ANOMALY.
SUMMARY: A POTENTIAL FALSE NEGATIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL OCCURRED ON (B)(6) 2024, AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. DUE TO THE BIOFIRE BCID2 PANEL, THE PATIENT'S RESULTS WERE DELAYED. 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. UPDATE FOR FOLLOW-UP REPORT: BIOFIRE IS STILL INVESTIGATING THIS EVENT IN ORDER TO DETERMINE THE ROOT CAUSE. THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 941249 | BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL | BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL | PAM | BIOFIRE DIAGNOSTICS, LLC | RFIT-ASY-0147 | 0715524 | 00815381020338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male |