BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABS2000

    MDR report key: 1012811 · Received March 17, 2008

    Report

    Report Number
    1034569-2008-00070
    Event Type
    Malfunction
    Date Received
    March 17, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 13, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK960019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESENCE OF THE E ANTIGEN WAS CONFIRMED ON RETENTION CRRS, LOTS G156 AND R020, AND CRRID, LOTS ID096 AND DP025. THE CUSTOMER DID NOT RETURN PRODUCT OR SAMPLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, AN UNEXPECTED NEGATIVE RESULT ON THE ABS2000. A B RH POSITIVE SAMPLE RESULTED WITH A NEGATIVE SCREEN WHEN TESTED ON THE ABS2000, BUT WAS REPORTED WITH A POSITIVE SCREEN WHEN TESTED ON THE ECHO. PATIENT RECEIVED 2 UNITS OF B POSITIVE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABS2000 AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR