BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 2651146 · Received July 11, 2012

    Report

    Report Number
    1056600-2012-00039
    Event Type
    Malfunction
    Date Received
    July 11, 2012
    Date of Event
    June 12, 2012
    Report Date
    July 11, 2012
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONFIRMED THAT THE REPORTED BLOOD GROUP DISCREPANCY WAS A RESULT OF THE TECH CLERICAL ERROR OF NOT VERIFYING THE SAMPLE ID ON THE REPORT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS DISCREPANT RESULTS IN THE ABO FORWARD TEST WHICH RESULTED IN AN INCORRECT BLOOD GROUP OF AB POS TO BE REPORTED FOR A PATIENT SAMPLE CONFIRMED TO BE A BLOOD GROUP OF O POS. INCORRECT RESULTS WERE REPORTED. TREATMENT WAS NOT ALTERED OR STOPPED DUE TO THE INCORRECT RESULTS REPORTED. CORRECT REPORTS HAVE BEEN ISSUED FOR THE AFFECTED SAMPLES. THERE WAS NO HARM TO ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1