BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATELIA ASPERGILLUS AG

    MDR report key: 3284288 · Received August 7, 2013

    Report

    Report Number
    3022521-2013-00001
    Event Type
    Malfunction
    Date Received
    August 7, 2013
    Date of Event
    July 10, 2013
    Report Date
    August 5, 2013
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    NOM
    PMA / PMN Number
    K093678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BIO-RAD LABORATORIES TECHNICAL SUPPORT RECEIVED A CALL ON (B)(4) 2013 FROM (B)(4) LAB PARTNERS TO REQUEST ASSISTANCE IN DETERMINING THE CAUSE OF LOW ODS OF THE CUT-OFF CONTROLS IN THE PLATELIA ASPERGILUS AG ASSAY. SPECIFICALLY, ASSAYS WERE REPORTED TO HAVE FAILED THE QC CRITERIA FOR THE CUT-OFF CONTROLS OVER THE LAST TWO MONTHS SINCE THE LABORATORY MOVED LOCATIONS. THE CUT-OFF CONTROL ODS FOR SOME ASSAY RUNS WERE BEING ADJUSTED BY THE CUSTOMER IN ORDER TO MEET QC CRITERIA REQUIREMENTS AND TO FACILITATE REPORTING OF PT RESULTS FROM THESE OTHERWISE INVALID ASSAY RUNS. PT RESULTS OBTAINED WITH THESE RUNS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371597 PLATELIA ASPERGILLUS AG IVD, EIA NOM BIO-RAD LABORATORIES, INC. 2J0118

    Patients

    Seq Age Sex Outcome Treatment
    1