BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABS2000

    MDR report key: 1033203 · Received April 25, 2008

    Report

    Report Number
    1034569-2008-00111
    Event Type
    Malfunction
    Date Received
    April 25, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 14, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK960019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REACTIVITY OF THE K ANTIGEN WAS CONFIRMED FOR RETENTION CAPTURE-R REASY-SCREEN (4), LOT G158, USED AT THE TIME OF THE COMPLAINT. REACTIVITY OF THE FYA ANITGEN WAS CONFIRMED THROUGH DHR REVIEW, SINCE PRODUCT EXPIRED DURING INVESTIGATION TESTING. A SERVICE VISIT WAS MADE. A 100UL BENT SYRINGE WAS REPLACED AND THE READER WINDOW WAS CLEANED. THE LEVEL SENSE FREQUENCY WAS OUT OF RANGE AND THE CENTRIFUGE SHAKE TEST OUT OF RANGE; BOTH SPECIFICATIONS WERE ADJUSTED. THE REPAIR HAS RETURNED THE INSTRUMENT TO OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON THE ABS2000. PATIENT SAMPLES WITH A HISTORY ANTI-KELL AND ANTI-FYA, RESPECTIVELY, WERE REPORTED AS ANTIBODY NEGATIVE ON THE ABS2000.

    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