BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FETALSCREEN II KIT

    MDR report key: 19789969 · Received July 22, 2024

    Report

    Report Number
    3011683976-2024-00012
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    July 5, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ALBA BIOSCIENCE LIMITED (LTD.)
    Product Code
    MTI
    PMA / PMN Number
    BK080051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT OF 3011683976-2024-0012.

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATION CONSISTED OF BOTH BATCH MANUFACTURING RECORD (BMR) REVIEWS AND INVESTIGATIVE TESTING. ROOT CAUSE HAS BEEN DETERMINED AS INCORRECT COMPOSITION OF THE POSITIVE CONTROL CELLS COMPONENT WITH FETALSCREEN II LOT V273985 AND FAILURE IN QC RELEASE TESTING. NO CLINICAL CONSEQUENCES HAVE BEEN REPORTED, AS QC FAILS AND CUSTOMERS DID NOT TESTED PATIENT SAMPLES. ALBA BIOSICENCE REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTS IDENTIFICATION OF A TREND ON QC FAILURE OF THE POSITIVE CONTROL WITH FETALSCREEN II KIT, PRODUCT CODE Z488, LOT V273985, EXPIRY 06AUG24. 95 COMPLAINTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119148 FETALSCREEN II KIT KIT, CELL SCREENING, FETAL MTI ALBA BIOSCIENCE LIMITED (LTD.) Z488 V273985
    230890 FETALSCREEN II KIT KIT, CELL SCREENING, FETAL MTI ALBA BIOSCIENCE LIMITED (LTD.) Z488 V273985

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown