BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFIRE® RESPIRATORY PANEL 2.1 (RP2.1)

    MDR report key: 22074228 · Received May 22, 2025

    Report

    Report Number
    3002773840-2025-00048
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    April 18, 2025
    Report Date
    June 20, 2025
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    QOF
    UDI-DI
    00815381020529
    PMA / PMN Number
    DEN200031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PATIENT DETAILS WERE NOT PROVIDED BY THE CUSTOMER. INFORMATION REGARDING THE SAMPLE TYPE USED FOR THE BIOFIRE RP2.1 TEST WAS ALSO NOT PROVIDED. ON (B)(6) 2025, A PATIENT'S UNKNOWN SAMPLE TYPE WAS TESTED ON THE BIOFIRE RP2.1. THE BIOFIRE RP2.1 REPORTED CORONAVIRUS 229E AS DETECTED. CEPHEID, THE LISTED COMPARATOR, DOES NOT DETECT CORONAVIRUS 229E. BIOFIRE ASKED WHETHER ANOTHER COMPARATOR ASSAY WAS PERFORMED TO CONFIRM THE CORONAVIRUS 229E RESULT, BUT NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER REPORTED A CEPHEID TEST WAS POSITIVE FOR SARS-COV-2. THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE RP2.1 RESULT, THE PATIENT WAS NOT TREATED AND EXPERIENCED A RESPIRATORY FAILURE. THE CUSTOMER DID NOT CLARIFY THE DURATION OF DELAY NOR IF THE RESPIRATORY FAILURE WAS REVERSIBLE. THE CUSTOMER IS UNRESPONSIVE TO PATIENT INFORMATION REQUESTS. THE ANALYSIS OF THE PROVIDED BIOFIRE RP2.1 RUN FILE SHOWED NO AMPLIFICATION NOR MELT ACTIVITY FOR SARS-COV-2 ASSAYS, BUT A VERY ROBUST SIGNATURE WAS OBSERVED FOR THE CORONAVIRUS 229E ASSAY. QUALITY CONTROL (QC) RECORDS FOR POUCH LOT# 3HTE24 (KIT LOT# 2093724) WERE REVIEWED. THIS POUCH LOT PASSED QC CRITERIA AND WAS FOUND WITHIN SPECIFICATIONS. NO RUN MALFUNCTION OCCURRED AT THE CUSTOMER SITE AND THE FILMARRAY INSTRUMENT (SERIAL NUMBER# (B)(6)) WAS WORKING WITHIN DESIGNED SPECIFICATIONS. CONCLUSION: THE INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN BIOFIRE RP2.1 AND COMPARATOR METHOD. THE BIOFIRE RP2.1 PANEL IS A HIGHLY SENSITIVE, QUALITATIVE MULTIPLEXED NUCLEIC ACID-BASED DIAGNOSTIC TEST INTENDED TO DETECT MULTIPLE BACTERIAL AND VIRAL NUCLEIC ACIDS DIRECTLY FROM NASOPHARYNGEAL SWABS (NPS) SPECIMENS. WHILE RARE, DISCREPANCIES BETWEEN THE BIOFIRE RP2.1 PANEL AND OTHER PCR METHODS CAN OCCUR AND ARE A PART OF NORMAL SYSTEM PERFORMANCE OBSERVED IN THE FIELD. THESE DISCREPANCIES CAN BE CAUSED BY DIFFERENCES IN CHEMISTRIES, ORGANISM/ASSAY TARGETS, PROCEDURES, SOFTWARE ANALYSIS, AND ASSAY CUT-OFF THRESHOLDS. RESULTS FROM THIS TEST MUST BE CORRELATED WITH THE CLINICAL HISTORY, EPIDEMIOLOGICAL DATA, AND OTHER DATA AVAILABLE TO THE CLINICIAN EVALUATING THE PATIENT. THE CUSTOMER DID NOT PROVIDE A COMPARATOR METHOD FOR CORONAVIRUS 229E. THE BIOFIRE RP2.1 SIGNATURE FOR CORONAVIRUS 229E WAS ROBUST, INDICATING THAT IT SHOULD BE EASILY REPRODUCIBLE BETWEEN BIOFIRE RUNS OR BETWEEN COMPARATOR METHODS. IT IS POSSIBLE THAT THIS WAS A TRUE DETECTION. THE CUSTOMER DID NOT STATE THE RATIONALE OR EVIDENCE THAT LED THEM TO THE CONCLUSION THAT THE CORONAVIRUS 229E ANALYTE WAS A FALSE POSITIVE. ACCORDING TO TABLE 3. OF THE BIOFIRE RP2.1 INSTRUCTIONS FOR USE (IFU) (WWW.ONLINE-IFU.COM/ITI0105), THE BIOFIRE RP2.1 CONTAINS TWO DIFFERENT ASSAYS FOR THE DETECTION OF SARS-COV-2. ONE ASSAY TARGETS THE SPIKE PROTEIN (S) GENE, AS THE OTHER ASSAY TARGETS THE MEMBRANE PROTEIN (M) GENE. THE BIOFIRE SOFTWARE INTERPRETS EACH ASSAY INDEPENDENTLY, AND IF EITHER ONE OR BOTH OF THE ASSAYS ARE POSITIVE, THE TEST REPORT WILL SHOW SARS-COV-2 AS DETECTED. IF BOTH ASSAYS ARE NEGATIVE, THE TEST REPORT RESULT WILL BE SARS-COV-2 NOT DETECTED. WHEREAS CEPHEID AMPLIFIES AND DETECTS UNIQUE SEQUENCES OF NUCLEOCAPSID (N), ENVELOPE (E), AND RNA-DEPENDENT RNA POLYMERASE (RDRP) GENES OF THE SARS-COV-2 VIRUS GENOME. AS WITH ALL PCR PRODUCTS, THERE IS A RISK OF FALSE POSITIVE RESULTS DUE TO CONTAMINATION WITH ORGANISMS, NUCLEIC ACIDS, VACCINE MATERIAL, AMPLIFIED PRODUCTS, CROSS-REACTIVITY WITH OTHER SIMILAR TARGETS, OR FROM NON-SPECIFIC SIGNALS IN THE ASSAY. A NEGATIVE BIOFIRE RP2.1 RESULT DOES NOT EXCLUDE THE POSSIBILITY OF VIRAL OR BACTERIAL INFECTION. NEGATIVE TEST RESULTS MAY OCCUR DUE TO THE PRESENCE OF SEQUENCE VARIANTS (OR MUTATION) IN THE REGION TARGETED BY THE ASSAY, THE PRESENCE OF INHIBITORS, TECHNICAL ERROR, SAMPLE MIX-UP, AN INFECTION CAUSED BY AN ORGANISM NOT DETECTED BY THE PANEL, OR LOWER RESPIRATORY TRACT INFECTION THAT IS NOT DETECTED BY A NASOPHARYNGEAL SWAB SPECIMEN. TEST RESULTS MAY ALSO BE AFFECTED BY THE LEVELS OF ORGANISM IN THE SPECIMEN THAT ARE BELOW THE LIMIT OF DETECTION FOR THE TEST. NEGATIVE RESULTS SHOULD NOT BE USED AS THE SOLE BASIS FOR DIAGNOSIS, TREATMENT, OR OTHER PATIENT MANAGEMENT DECISIONS. CLINICAL PERFORMANCE FOR SARS-COV-2 CAN BE FOUND IN TABLES 19, 24, AND 27 OF THE BIOFIRE RP2.1 IFU CLINICAL PERFORMANCE FOR COV-229E CAN BE FOUND IN TABLES 14 AND 22 OF THE BIOFIRE RP2.1 PANEL INSTRUCTIONS FOR USE (WWW.ONLINE-IFU.COM/ITI0105).

    Additional Manufacturer Narrative · 0

    INVESTIGATION: (B)(6) HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE SARS-COV-2 RESULT AND FALSE POSITIVE CORONAVIRUS COV-229E ON THE BIOFIRE RESPIRATORY PANEL 2.1 (RP2.1) PANEL AFTER TESTING A PATIENT SAMPLE. THE CUSTOMER DID NOT CLARIFY THE DURATION OF DELAY NOR IF THE RESPIRATORY FAILURE WAS REVERSIBLE. THE CUSTOMER IS UNRESPONSIVE TO PATIENT INFORMATION REQUESTS. BIOFIRE'S INVESTIGATION INTO THIS EVENT IS ONGOING AND THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. QC RECORDS FOR KIT/POUCH LOT 2093724/3HTE24 AND INSTRUMENT TM13656 WERE REVIEWED. ALL QC METRICS FOR THE POUCH LOT AND INSTRUMENT WERE MET AND PASSED QC. THE DISCREPANCY REPORTED BY THE CUSTOMER WAS NOT OBSERVED DURING QC TESTING OF THIS LOT. CONCLUSION: INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    SUMMARY: (B)(6) HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2) RESULT AND A FALSE POSITIVE CORONAVIRUS 229E ON THE BIOFIRE RESPIRATORY PANEL 2.1 (RP2.1) PANEL AFTER TESTING A PATIENT SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE RP2.1 RESULT, THE PATIENT WAS NOT TREATED AND EXPERIENCED RESPIRATORY FAILURE. THE INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS SENSITIVITY/SPECIFICITY DIFFERENCES BETWEEN BIOFIRE RP2.1 AND A COMPARATOR METHOD.

    Description of Event or Problem · 0

    SUMMARY: (B)(6) HOSPITAL (B)(6) REPORTED A POTENTIAL FALSE NEGATIVE SARS-COV-2 RESULT AND FALSE POSITIVE CORONAVIRUS COV-229E ON THE BIOFIRE RESPIRATORY PANEL 2.1 (RP2.1) PANEL AFTER TESTING A PATIENT SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE RP2.1 RESULT, THE PATIENT WAS NOT TREATED AND EXPERIENCED RESPIRATORY FAILURE. NO REMEDIAL ACTION, CORRECTIVE ACTION, PREVENTIVE ACTION, OR FIELD SAFETY CORRECTIVE ACTION (FSCA) HAS BEEN DEEMED NECESSARY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818778 BIOFIRE® RESPIRATORY PANEL 2.1 (RP2.1) BIOFIRE® RESPIRATORY PANEL 2.1 (RP2.1) QOF BIOFIRE DIAGNOSTICS, LLC 423742 2093724 00815381020529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other