BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIS SHIELD ACTIVE-B12 EIA

    MDR report key: 19760113 · Received July 17, 2024

    Report

    Report Number
    8032314-2024-00001
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 19, 2024
    Report Date
    October 25, 2024
    Manufacturer
    AXIS-SHIELD DIAGNOSTICS, LTD.
    Product Code
    CDD
    UDI-DI
    05055845400046
    PMA / PMN Number
    K121946
    Removal / Correction Number
    YES - 2 CORRECTIVE ACTIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONFIRMED WITH CUSTOMER THAT THEY HAVE NO AFFECTED TEST KIT REMAINING TO RETURN.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE WAS IDENTIFIED AS A LINE CLEARANCE FAILURE DURING THE PACKING OPERATION FOR FMABT100 902959842. SPECIFICALLY, THE LABELLING ACTIVITY FOR THE LOW AND HIGH CONTROL VIALS WAS PERFORMED IN THE SAME WORK ZONE, AT THE SAME TIME, LEADING TO MISLABELLING OF THE CONTROLS. THE ROOT CAUSE FOR THIS CAPA IS THEREFORE ASSIGNED TO METHOD - INADEQUATE CONTROLS.

    Description of Event or Problem · 0

    AXIS-SHIELD DIAGNOSTICS LTD. RECEIVED NOTIFICATION OF A COMPLAINT ON (B)(6) 2024 STATING THE CUSTOMER HAD EXPERIENCED OUT OF RANGE RESULTS, RELATING TO THE HIGH AND LOW CONTROLS REPORTING RESULTS OUT OF RANGE, WHEN USING FMABT100 LOT 902959842. THERE WAS NO IMPACT TO PATIENT. THE CUSTOMER HAD AN ADDITIONAL LOT THAT DID NOT DISPLAY THE SAME ERROR AND WAS ABLE TO PROCEED WITH TESTING.

    Description of Event or Problem · 0

    AXIS-SHIELD DIAGNOSTICS LTD. RECEIVED NOTIFICATION OF A COMPLAINT ON 19TH JUNE 2024 STATING THE CUSTOMER HAD EXPERIENCED OUT OF RANGE RESULTS, RELATING TO THE HIGH AND LOW CONTROLS REPORTING RESULTS OUT OF RANGE, WHEN USING FMABT100 LOT 902959842. THERE WAS NO IMPACT TO PATIENT. THE CUSTOMER HAD AN ADDITIONAL LOT THAT DID NOT DISPLAY THE SAME ERROR AND WAS ABLE TO PROCEED WITH TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2518695 AXIS SHIELD ACTIVE-B12 EIA RADIOASSAY, VITAMIN B12 CDD AXIS-SHIELD DIAGNOSTICS, LTD. FMABT100 902959842 05055845400046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown