BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM

    MDR report key: 15476266 · Received September 24, 2022

    Report

    Report Number
    3007420875-2022-00050
    Event Type
    Malfunction
    Date Received
    September 24, 2022
    Date of Event
    September 7, 2022
    Report Date
    September 28, 2022
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER ADDITIONAL REVIEW, MFR REPORT # 3007420875-2022-00050 WAS SUBMITTED IN ERROR. THIS DEVICE IS CONSIDERED EXEMPT. THIS MDR SHOULD BE CONSIDERED CANCELED.

    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 BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM LOT NUMBER INDICATED ON 30 BOXES IS NOT THE SAME LOT NUMBER INDICATED ON THE REAGENT STRIPS. THE USER REALIZED THE BOXES HAD BEEN RELABELED. THE LABEL ON THE BOTTOM OF THE BOX HAS THE SAME LOT NUMBER AS THE STRIPS BUT THERE IS NO REFERENCE TO THE KIT. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LOT INDICATED ON THE BOX (2192582) IS NOT THE SAME AS THE LOT INDICATED ON THE REAGENT STRIPS (2049520). THE USER REALIZED THAT THE BOXES HAD BEEN RELABELED. THE LABEL ON THE BOTTOM HAS THE SAME LOT NUMBER AS THE STRIPS (2049520) BUT THERE IS NO REFERENCE TO THE KIT, WHICH IS PROBABLY WHY IT WAS RELABELED. 30 BOXES ARE CONCERNED. THE LABORATORY PERFORMED A POSITIVE CONTROL ON ONE STRIP. THIS CONTROL WAS COMPLIANT (POS SARS-COV-2/POS FLU).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM LOT NUMBER INDICATED ON 30 BOXES IS NOT THE SAME LOT NUMBER INDICATED ON THE REAGENT STRIPS. THE USER REALIZED THE BOXES HAD BEEN RELABELED. THE LABEL ON THE BOTTOM OF THE BOX HAS THE SAME LOT NUMBER AS THE STRIPS BUT THERE IS NO REFERENCE TO THE KIT. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LOT INDICATED ON THE BOX (2192582) IS NOT THE SAME AS THE LOT INDICATED ON THE REAGENT STRIPS (2049520). THE USER REALIZED THAT THE BOXES HAD BEEN RELABELED. THE LABEL ON THE BOTTOM HAS THE SAME LOT NUMBER AS THE STRIPS (2049520) BUT THERE IS NO REFERENCE TO THE KIT, WHICH IS PROBABLY WHY IT WAS RELABELED. 30 BOXES ARE CONCERNED. THE LABORATORY PERFORMED A POSITIVE CONTROL ON ONE STRIP. THIS CONTROL WAS COMPLIANT (POS SARS-COV-2/POS FLU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435557 BD SARS-COV-2/FLU FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 2049520

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown