BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL
Report
- Report Number
- 3002773840-2024-00381
- Event Type
- Malfunction
- Date Received
- September 12, 2024
- Date of Event
- August 2, 2024
- Report Date
- November 7, 2024
- Manufacturer
- BIOFIRE DIAGNOSTICS, LLC
- Product Code
- PAM
- UDI-DI
- 00815381020338
- PMA / PMN Number
- K193519
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION: A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BCID2 PANEL WAS REPORTED AFTER TESTING A PATIENT'S POSITIVE BLOOD CULTURE SAMPLE ON (B)(6) 2024. GRAM-POSITIVE COCCI WERE OBSERVED ON GRAM STAIN. S. MARCESCENS WAS NOT RECOVERED FROM CULTURE. IT IS UNKNOWN IF THE PATIENT WAS AFFECTED OR HARMED DUE TO THE BIOFIRE BCID2 PANEL RESULT. 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 FINAL REPORT. 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.
INVESTIGATION: A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BCID2 PANEL WAS REPORTED AFTER TESTING A PATIENT'S POSITIVE BLOOD CULTURE SAMPLE ON (B)(6) 2024. GRAM-POSITIVE COCCI WERE OBSERVED ON GRAM STAIN. S. MARCESCENS WAS NOT RECOVERED FROM CULTURE. IT IS UNKNOWN IF THE PATIENT WAS AFFECTED OR HARMED DUE TO THE BIOFIRE BCID2 PANEL RESULT. 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 FINAL REPORT. CONCLUSION: N/A FOR INITIAL REPORT.
INVESTIGATION: A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BCID2 PANEL WAS REPORTED AFTER TESTING A PATIENT'S POSITIVE BLOOD CULTURE SAMPLE ON (B)(6) 2024. GRAM-POSITIVE COCCI WERE OBSERVED ON GRAM STAIN. S. MARCESCENS WAS NOT RECOVERED FROM CULTURE. IT IS UNKNOWN IF THE PATIENT WAS AFFECTED OR HARMED DUE TO THE BIOFIRE BCID2 PANEL RESULT. NO SERIOUS INJURY OR DEATH WAS REPORTED. THE CUSTOMER REPORTED THAT THE PATIENT BLOOD SAMPLE WAS COLLECTED IN A BIOMÉRIEUX BACT/ALERT BLOOD CULTURE BOTTLE LOT # 0004102408 OR LOT # 0004061294. THE CUSTOMER COULD NOT DEFINITIVELY IDENTIFY THE BLOOD CULTURE BOTTLE LOT USED TO COLLECT THE PATIENT SAMPLE; HOWEVER, IT IS LIKELY IT WAS COLLECTED IN BIOMÉRIEUX BACT/ALERT BLOOD CULTURE BOTTLE LOT # 0004102408. CUSTOMER TESTING OF BIOMÉRIEUX BACT/ALERT BLOOD CULTURE BOTTLE LOT # 0004102408 CONFIRMED THE PRESENCE OF S. MARCESCENS NON-VIABLE ORGANISMS AND/OR NUCLEIC ACID IN THE BLOOD CULTURE MEDIA. CUSTOMER TESTING OF BIOMÉRIEUX BACT/ALERT BLOOD CULTURE BOTTLE LOT # 0004061294 DID NOT CONFIRM THE PRESENCE OF S. MARCESCENS NON-VIABLE ORGANISMS AND/OR NUCLEIC ACID IN THE BLOOD CULTURE MEDIA. ADDITIONALLY, QC TESTING FOR BIOMÉRIEUX BACT/ALERT BLOOD CULTURE BOTTLE LOT # 0004061294 DID NOT INDICATE ANY UNEXPECTED S. MARCESCENS DETECTIONS DURING QC TESTING AND NO OTHER CUSTOMERS HAVE REPORTED FALSE POSITIVE S. MARCESCENS RESULTS IN PATIENT SAMPLE COLLECTED WITH THIS BLOOD CULTURE BOTTLE LOT. UNINOCULATED BLOOD CULTURE BOTTLES FROM LOT # 0004061294 WERE REQUESTED FROM THE CUSTOMER FOR INTERNAL INVESTIGATION OUT OF AN ABUNDANCE OF CAUTION; HOWEVER, THE CUSTOMER DID NOT RESPOND TO MULTIPLE REQUESTS AND FURTHER CONFIRMATION OF THE ABSENCE OF S. MARCESCENS NON-VIABLE ORGANISM AND/OR NUCLEIC ACID IN THE BLOOD CULTURE MEDIA (LOT # 0004061294) COULD NOT BE COMPLETED. CONCLUSION: THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE (LIKELY FROM BIOMÉRIEUX BACT/ALERT BLOOD CULTURE BOTTLE LOT # 0004102408). SIMILAR EVENTS WERE RECENTLY OBSERVED IN THE FIELD WITH THE COMBINATION OF THE BIOFIRE BCID2 PANEL AND SPECIFIC LOTS OF BACT/ALERT® CULTURE MEDIA BOTTLES. WHILE BLOOD CULTURE VIALS ARE AUTOCLAVED AND ROUTINELY QUALITY CONTROLLED FOR STERILITY, NON-VIABLE ORGANISMS OR NUCLEIC ACIDS CAN REMAIN IN THE BLOOD CULTURE MEDIA AFTER THE STERILIZATION PROCESS. THE PRESENCE OF NON-VIABLE ORGANISMS AND NUCLEIC ACID DOES NOT COMPROMISE THE INTENDED USE OF BLOOD CULTURE MEDIA, CULTURING VIABLE MICROORGANISMS; HOWEVER, THE BIOFIRE BCID2 PANEL DOES NOT DISTINGUISH BETWEEN NUCLEIC ACID FROM VIABLE OR NON-VIABLE ORGANISMS. THE "LABORATORY PRECAUTION" AND "LIMITATION" SECTIONS OF THE BIOFIRE BCID2 PANEL INSTRUCTIONS FOR USE (IFU) (WWW.ONLINE-IFU.COM/ITI0048) OUTLINES THE POTENTIAL FOR FALSE POSITIVE DETECTIONS DURING MOLECULAR TESTING WITH STERILE BLOOD CULTURE MEDIA CONTAINING DETECTABLE LEVELS OF NON-VIABLE ORGANISMS AND/OR NUCLEIC ACID. IMPORTANTLY, RESULTS FROM THE BIOFIRE BCID2 PANEL ARE INTENDED TO BE CORRELATED WITH THE CLINICAL HISTORY, EPIDEMIOLOGICAL DATA, AND OTHER DATA AVAILABLE TO THE CLINICIAN EVALUATING THE PATIENT. ALL IDENTIFICATION RESULTS PROVIDED BY THE BIOFIRE BCID2 PANEL ARE INTENDED TO BE INTERPRETED IN CONJUNCTION WITH GRAM STAIN RESULTS. IN ORDER TO DEFINITIVELY CONCLUDE THE CAUSE OF THE DISCREPANCY, INTERNAL INVESTIGATION OF THE BLOOD CULTURE MEDIA WOULD NEED TO BE CONDUCTED. IT IS POSSIBLE THAT THE DISCREPANT S. MARCESCENS RESULT COULD BE DUE TO SOME OTHER CAUSE SUCH AS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN THE BIOFIRE BCID2 PANEL AND CULTURE OR CONTAMINATION. CLINICAL PERFORMANCE: ACCORDING TO TABLE 33. BIOFIRE BCID2 PANEL CLINICAL PERFORMANCE SUMMARY, ENTEROBACTERALES OF THE BIOFIRE BCID2 PANEL IFU, THE PERFORMANCE CLAIM FOR THE S. MARCESCENS ASSAY COMPARED TO STANDARD MANUAL AND AUTOMATED MICROBIOLOGICAL/BIOCHEMICAL IDENTIFICATION METHODS SHOWED AN OVERALL SENSITIVITY OF 100% (95% CI 87.5-100%) AND AN OVERALL SPECIFICITY OF 100% (95% CI 99.7-100%).
SUMMARY: INVERSIONES SAGRAV, S.A. (PANAMA CITY, PANAMA) REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS AFFECTED OR HARMED 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. 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.
SUMMARY: INVERSIONES SAGRAV, S.A. (PANAMA CITY, PANAMA) REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS AFFECTED OR HARMED 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.
SUMMARY: (B)(6) REPORTED A POTENTIAL FALSE POSITIVE SERRATIA MARCESCENS RESULT ON THE BIOFIRE BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL AFTER TESTING A PATIENT BLOOD CULTURE SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS AFFECTED OR HARMED DUE TO THE BIOFIRE BCID2 PANEL RESULT. NO SERIOUS INJURY OR DEATH WAS REPORTED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE DISCREPANT S. MARCESCENS RESULT WAS THE PRESENCE OF NON-VIABLE ORGANISM/NUCLEIC ACID IN THE BLOOD CULTURE MEDIA BOTTLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557784 | BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL | BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL | PAM | BIOFIRE DIAGNOSTICS, LLC | RFIT-ASY-0147 | 2149723 | 00815381020338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Male |