BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    MDR report key: 3973578 · Received August 1, 2014

    Report

    Report Number
    2250051-2014-00083
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    May 19, 2014
    Report Date
    August 1, 2014
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAIN TESTING, BATCH REVIEW AND COMPLAINT REVIEW BY LOT. ALL RESULTS WERE SATISFACTORY. ACTUAL GEL CARD OR SAMPLE WAS NOT AVAILABLE TO BE SENT TO OCD FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    OCD REP REPORTED FOR A CUSTOMER WHO HAD DISCREPANT RHESUS RESULTS WHEN TESTING A PATIENT'S SAMPLE ON TWO SEPARATE OCCASIONS. ACCORDING TO THE OCD REP, THE PATIENT'S SAMPLE WAS FIRST TESTED ON (B)(6) 2014 USING ABD/ REV GEL CARDS LOT # 100113037-60 ON PROVUE AND RHESUS RESULT WAS REPORTED AS RH NEGATIVE. A SECOND SAMPLE WAS TESTED ON (B)(6) 2014, AGAIN ON PROVUE BUT USING AN ALTERNATIVE LOT OF MTS ABD/ REV GEL CARDS AND NOW THE SAMPLE IS REACTING 2+ WITH ANTI-D MICROWELL. SAMPLE WAS RETESTED USING TUBE METHOD WITH IMMUCOR ANTI-D ANTISERA AND THE RESULT WAS POSITIVE AT AHG PHASE (1+). NO DATE TESTING WAS PERFORMED. PATIENT IS 28 WEEKS PREGNANT. QC WAS RUN ON THE DAY OF USE AND WAS ACCEPTABLE. ALL REAGENTS AND GEL CARDS HAD ACCEPTABLE APPEARANCE PRIOR TO USE AND HAD BEEN STORED AS PER THE IFU. MAINTENANCE OF THE PROVUE INSTRUMENT WAS ACCEPTABLE. NO SAMPLE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451089 MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD BLOOD TYPING REAGENT KSZ ORTHO CLINICAL DIAGNOSTICS 100113037-60

    Patients

    Seq Age Sex Outcome Treatment
    1