BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 6303338 · Received February 6, 2017

    Report

    Report Number
    1056600-2017-00005
    Event Type
    Malfunction
    Date Received
    February 6, 2017
    Date of Event
    January 6, 2017
    Report Date
    February 6, 2017
    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 AN ORTHO FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE ON 01-10-17 AND PERFORMED CAMERA ADJUSTMENT, BRIGHTNESS WAS AT 120 (101-128). THE ROOT-CAUSE COULD NOT BE CONFIRMED ALTHOUGH THE MOST PROBABLE ROOT CAUSE IS ASSOCIATED WITH AN ANTIBODY BEING WEAK AND/OR AT THE DETECTION LIMIT OF THE TECHNIQUE AND REAGENTS USED. NO INCORRECT OR ERRONEOUS RESULTS WERE REPORTED AS A RESULT OF THIS INCIDENT. THERE WAS NO RISK PRESENT AT THE TIME OF THE INCIDENT. THERE WAS NO HARM TO ANY PATIENT.

    Description of Event or Problem · 1

    FALSE NEGATIVE ANTIBODY SCREENING RESULT OBTAINED ON A PATIENT SAMPLE, TESTED ON THE PROVUE ANALYZER ON (B)(6) 2017 WITH IGG GEL CARDS 072516001-18 (EXP: JUNE 21 2017) AND SURGISCREEN CELLS LOT: VSS875 (EXP: JAN 31 2017). THE SAME PATIENT WAS TESTED ON (B)(6) WITH THE SAME GEL CARDS LOT, RESULTS WERE 1+. A POSITIVE REACTION WAS OBTAINED DURING A CROSSMATCH WHICH LED TO MANUAL TESTING USING THE SAME REAGENTS AND GEL CARDS, RESULTS WERE POSITIVE. THE SAMPLE WAS THEN REPEATED ON PROVUE USING DIFFERENT GEL CARD LOT, RESULTS WERE POSITIVE. THE PATIENT HAD A HISTORY OF NON SPECIFIC COLD ANTIBODY AND WAS LAST TRANSFUSED IN 2013. NO FALSE NEGATIVE RESULT REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88558 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1