BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM

    MDR report key: 12558282 · Received September 30, 2021

    Report

    Report Number
    2647876-2021-00138
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 3, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAXTM SYSTEM KIT (REF 44500301) LOT 1120402 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD SARS-COV-2 REAGENTS FOR BD MAXTM SYSTEM INDICATED THAT LOT 1120402 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED POTENTIAL FALSE COV2 POSITIVE RESULTS AS ONLY ONE OF THE TWO TARGETS WAS POSITIVE. THE SPECIFIC POSITIVE TARGET (N1 OR N2) WAS NOT IDENTIFIED IN THE COMMUNICATION. DESPITE MULTIPLE ATTEMPTS MADE TO RECEIVE INFORMATION FROM THE CUSTOMER, NO DATA WAS PROVIDED FOR THE INVESTIGATION. WITHOUT ANY DATA PROVIDED, NO ANALYSIS WAS POSSIBLE, AND THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD WAS UNABLE TO CONFIRM THE ROOT CAUSE OF THE CUSTOMER ISSUE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD SARS-COV-2 REAGENTS FOR BD MAX¿ LOT 1120402. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 9 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEMS GAVE FALSE POSITIVE TEST RESULTS FOLLOWING TESTING. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S INFORMATION, FALSE POSITIVES ARE SUSPECTED AS ONLY ONE SIDE OF THE N1 AND THE N2 SHOW POSITIVES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 9 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEMS GAVE FALSE POSITIVE TEST RESULTS FOLLOWING TESTING. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S INFORMATION, FALSE POSITIVES ARE SUSPECTED AS ONLY ONE SIDE OF THE N1 AND THE N2 SHOW POSITIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449591 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON DICKINSON CARIBE LTD. 1120402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown