BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1221522 · Received November 5, 2008

    Report

    Report Number
    1056600-2008-00336
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 5, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUBMITTED A SAMPLE TO OCD FOR ADDITIONAL INVESTIGATION. CUSTOMER COMPLAINT WAS NOT CONFIRMED. THE SAMPLE REACTED POSITIVE (2+) IN THE ANTI-D MICROTUBE IN MANUAL GEL TEST AND ON THE PROVUE USING RETAINED CARDS FROM LOT # 121707053-10. THE RESULTS OBTAINED WITH MANUAL GEL TEST WERE CONCORDANT WITH THE PROVUE TEST RESULTS. THE SAMPLE WAS TYPED AS GROUP O RH POSITIVE AT OCD. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE ANALYZER INTERPRETED THE RESULTS OF A GROUP O RH POSITIVE DONOR SEGMENT AS RH NEGATIVE DURING RETYPE. THE SAMPLE WAS CONFIRMED IN TUBE METHOD TO BE A WEAK D SAMPLE. NO ERRONEOUS RESULTS WERE REPORTED. FALSE NEGATIVE TEST RESULTS CAN LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYST KSZ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1