BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    MDR report key: 11267821 · Received February 2, 2021

    Report

    Report Number
    1119779-2021-00216
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Date of Event
    January 7, 2021
    Report Date
    April 1, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR INCORRECT LABELLED MASTER MIX POUCHES IN THE BIOGX SARS-COV-2 OSR ASSAY (REF #444213) KIT LOT K20-509 WAS PERFORMED BY BIOGX, PRODUCT MANUFACTURER. THE INVESTIGATION WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S PICTURE AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER REPORTED THAT THAT THE N2 REAGENT POUCH HAD ORANGE FOIL REAGENT AND N1 REAGENT POUCH ALSO HAD ORANGE FOIL REAGENT AND PROVIDED PICTURE FOR INVESTIGATION. THE PICTURES SHOW A POUCH WITH N2 LABEL CONTAINING REAGENT TUBES WITH ORANGE FOIL SEALS. REMINDER THE MASTER MIX TUBES ARE COLOR-CODED: N1 TUBES USE ORANGE FOIL SEALS AND N2 TUBES USE RED FOIL SEALS. BIOGX CONFIRMED THAT MASTER MIX POUCHES EXTERNALLY LABELED AS CONTAINING N2 TUBES WERE CONTAINING N1 TUBES. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THIS KIT LOT K20-509 WAS AFFECTED BY A HUMAN ERROR. A CHANGE OF PACKAGING SITE HAS CONTRIBUTED TO A HUMAN ERROR DURING THE LABELLING PROCESS OF MASTER MIX POUCHES. BIOGX CONFIRM THE COMPLAINT BASED ON THE REVIEW OF MANUFACTURING RECORD AND THE PICTURE PROVIDED. THERE IS AN INDICATION OF AN INCREASE IN COMPLAINTS FOR INCORRECT LABELLING IN THE BIOGX SARS-COV-2 OSR PRODUCT. THE ROOT CAUSE OF THE CUSTOMER ISSUE WAS A HUMAN ERROR DURING LABELLING PROCESS. BIOGX PRODUCT MANUFACTURER HAS INITIATED A PREVENTIVE AND CORRECTIVE ACTION PLAN. BD HAS ALSO INITIATED A CAPA (2208364).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM THE N2 REAGENT IN POUCH HAD ORANGE CAP INSTEAD OF RED. (B)(4).

    Additional Manufacturer Narrative · 1

    EUA# (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM THE N2 REAGENT IN POUCH HAD ORANGE CAP INSTEAD OF RED. EUA# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163143 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) K20-509

    Patients

    Seq Age Sex Outcome Treatment
    1