BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 5904453 · Received August 25, 2016

    Report

    Report Number
    1056600-2016-00070
    Event Type
    Malfunction
    Date Received
    August 25, 2016
    Date of Event
    July 27, 2016
    Report Date
    August 25, 2016
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSTRUMENT HAS BEEN INVESTIGATED. ON (B)(6) 2016 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND FOUND THE GEL CARD CROOKED ON THE GRIPPER. THE FE ADJUSTED THE "Y" POSITION ON GRIPPER. THE FE DID A PM AS PER CHECKLIST. THE FE RAN DIAGNOSTICS, ALL DIAGNOSTIC CHECKS ARE OK. THE PROVUE CAMERA VALUE SET AT 109 (RANGE IS 101-128). THE CUSTOMER RAN AND ACCEPTED CONTROLS. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE ORTHO PROVUE GAVE (B)(6) SCREEN RESULTS ON A PATIENT THAT WAS WEAK (B)(6) BY VISUAL INSPECTION OF THE GEL CARD. NO INCORRECT RESULTS WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555115 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1