BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1835933 · Received September 15, 2010

    Report

    Report Number
    1056600-2010-00115
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 10, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD FIELD ENGINEERS PERFORMED REQUIRED REPAIRS TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED POSSIBLE CARRYOVER DURING ANTIBODY SCREEN TESTING. A RETROSPECTIVE REVIEW INDICATES THAT A PRENATAL PATIENT HAD ANTI-C (128), ANTI-E (128) AND ANTI-K (8). CARRY OVER WAS SEEN WITH THE ANTI-C AND ANTI-E BUT NOT WITH ANTI-K. NO ERRONEOUS RESULTS REPORTED ON ANY SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 2.16

    Patients

    Seq Age Sex Outcome Treatment
    1