BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 1505037 · Received September 25, 2009

    Report

    Report Number
    1056600-2009-00214
    Event Type
    Malfunction
    Date Received
    September 25, 2009
    Date of Event
    September 3, 2009
    Report Date
    September 25, 2009
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE ROOT CAUSE WAS DETERMINED. AN OCD FIELD ENGINEER ARRIVED AT THE CUSTOMER SITE AND ADJUSTED THE READER CAMERA AND PERFORMED A REFERENCE CARD TEST. SERVICE HAS RETURNED THE INSTRUMENT TO EXPECTED OPERATION. A SEARCH WAS PERFORMED CONCERNING COMPLAINTS LOGGED BY THIS CUSTOMER. THIS CUSTOMER HAS NOT LOGGED ANY SIMILAR COMPLAINTS AGAINST THIS ANALYZER SINCE THIS INCIDENT. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ORTHO PROVUE ANALYZER READ A CLEAR NEGATIVE RESULT AS A 1+ POSITIVE REACTION IN THE FIRST MICROTUBE WHEN PERFORMING ABO AND RH TYPING. THE PROVUE POSTED A NRD (NO RESULT DETERMINED) ERROR MESSAGE SINCE THE FORWARD AND REVERSE GROUPING DID NOT MATCH. NO ERRONEOUS RESULTS WERE REPORTED. A FALSE POSITIVE RESULT MAY LEAD TO THE MISCLASSIFICATION OF A PT'S ABO GROUP, WITH THE POTENTIAL FOR TRANSFUSION OF ABO 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