BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD MAX ENTERIC VIRAL PANEL

    MDR report key: 15844425 · Received November 22, 2022

    Report

    Report Number
    3007420875-2022-00072
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    November 10, 2022
    Report Date
    January 4, 2023
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCH
    UDI-DI
    00382904439859
    PMA / PMN Number
    K181427
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE AND FALSE NEGATIVE RESULTS WHEN USING THE BD MAX ENTERIC VIRAL PANEL ASSAY (REF. 443985) LOT 2102313 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX ENTERIC VIRAL PANEL (EVP) INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT ONE SAMPLE WHICH INITIALLY TESTED NOV, SAV AND HASTV POSITIVE (RUN 1383 A10) BUT WAS NEGATIVE FOR ALL THE TARGETS UPON REPEAT (RUN 1385 B12) WITH THE BD MAX¿ ENTERIC VIRAL PANEL ASSAY FROM LOT 2102313. CUSTOMER PROVIDED THE DATABASE FROM INSTRUMENT CT1563 FOR INVESTIGATION AND RUNS 1383 AND 1385 WERE EXTRACTED. MANUAL PCR CURVE ADJUDICATION OF THE DISCREPANT SAMPLE SHOWED WHAT APPEARS TO BE AN ATYPICAL CURVE FOR THE NOV AND HASTV WHICH LED TO A POSITIVE RESULT IN RUN 1383 LANE A10. IT IS UNLIKELY THAT THIS ATYPICAL CURVE FOR BOTH TARGETS IS THE RESULT OF TRUE AMPLIFICATION AND A PUNCTUAL ISSUE FROM UNKNOWN ORIGIN IS SUSPECTED. MOREOVER, THE REPEAT TEST SHOWS FLAT CURVES WITH NO AMPLIFICATION NOR ANY ANOMALY FOR BOTH TARGETS. THE CURVE FOR THE SAV TARGET REVEALED LATE AND LOW, BUT TRUE POSITIVE AMPLIFICATION IN BOTH INITIAL AND REPEAT TESTS, BUT IT DID NOT REACH THE THRESHOLD TO BE POSITIVE IN THE SECOND TEST. A SAMPLE AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) IS THE MOST LIKELY CAUSE TO EXPLAIN THE POSITIVE SAV RESULT. ENVIRONMENTAL OR CROSS CONTAMINATION DURING THE SAMPLE PREPARATION COULD ALSO BE IN CAUSE. NEVERTHELESS, MANUAL PCR CURVE ADJUDICATION AND VISUAL EXAMINATION OF ATYPICAL PCR CURVES AND LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX ENTERIC VIRAL PANEL LOT 2102313. THE ROOT CAUSE WAS NOT IDENTIFIED. NONETHELESS, NO REAGENTS ISSUE IS SUSPECTED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION PLAN (CAPA) SINCE NO REAGENT ISSUE WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. SEE H.10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT KIT BD MAX ENTERIC VIRAL PANEL FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED WAS RUNNING THE PATIENT TEST AND ALMOST ALL VIRALS CAME AS POSITIVE. HAZARD, INJURY OR ERRONEOUS RESULTS? YES DID A DEATH OCCUR? NO DID A SERIOUS INJURY OCCUR? NO DID ERRONEOUS RESULTS OCCUR? YES IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): REVIEW LOG AND DATABASE 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? DIFFERENT RESULTS 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) PENDING REVIEW 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? PENDING ADDITIONAL INFORMATION 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? PENDING ADDITIONAL INFORMATION 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? PENDING ADDITIONAL INFORMATION DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT KIT BD MAX ENTERIC VIRAL PANEL FALSE POSITIVES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED WAS RUNNING THE PATIENT TEST AND ALMOST ALL VIRALS CAME AS POSITIVE. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. DID A DEATH OCCUR? NO. DID A SERIOUS INJURY OCCUR? NO. DID ERRONEOUS RESULTS OCCUR? YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): REVIEW LOG AND DATABASE: 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? DIFFERENT RESULTS. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) PENDING REVIEW. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? PENDING ADDITIONAL INFORMATION. 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? PENDING ADDITIONAL INFORMATION. 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? PENDING ADDITIONAL INFORMATION. DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897341 KIT BD MAX ENTERIC VIRAL PANEL GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443985 2102313 00382904439859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown