BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11298022 · Received February 8, 2021

    Report

    Report Number
    1119779-2021-00271
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 19, 2021
    Report Date
    February 9, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COMPLAINT INVESTIGATION FOR INCORRECT LABELLED MASTER MIX POUCHES IN THE BIOGX SARS-COV-2 OSR ASSAY (REF #(B)(4)) KIT LOT K21-020 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 N1 AND N2 MASTER MIX POUCHES HAD ORANGE FOIL TUBES. 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 SOME KITS OF LOT K21-020 WERE AFFECTED BY THE ISSUE. 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 CAPA#(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POUCH IS LABELED FOR N2 BUT THE SNAP INS HAVE ORANGE FOIL INSTEAD OF RED WITH A BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM. EUA# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POUCH IS LABELED FOR N2 BUT THE SNAP INS HAVE ORANGE FOIL INSTEAD OF RED WITH A BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM. EUA# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188678 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) K21-020

    Patients

    Seq Age Sex Outcome Treatment
    1