BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FMH RAPIDSCREEN

    MDR report key: 4060889 · Received September 4, 2014

    Report

    Report Number
    1034569-2014-00163
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 8, 2014
    Report Date
    September 4, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    LIM
    PMA / PMN Number
    BK110067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR LABORATORY RECEIVED RETURNED SAMPLE (B)(4) ON (B)(4) 2014, HOWEVER WAS UNABLE TO TEST IT BECAUSE IT WAS BEYOND THE PRESCRIBED USABILITY DATES. THE IMMUCOR LABORATORY DID HOWEVER TEST RETENTION FMH RAPIDSCREEN PRODUCT WHICH PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING FMH RAPIDSCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542900 FMH RAPIDSCREEN TEST, SCREENING, FOR D POSITIVE FETAL RBC'S LIM IMMUCOR, INC. 24516

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR