BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS A/B/D MONOCLONAL GROUPING CARD

    MDR report key: 1693181 · Received May 18, 2010

    Report

    Report Number
    1056600-2010-00053
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    September 26, 2009
    Report Date
    May 18, 2010
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PROVUE WAS OPERATING WITHOUT ISSUE OR ERROR ON THE DAYS OF TESTING. ALL REAGENTS AND GEL CARDS WERE STORED AS PER PACKAGE INSERTS AND APPEARED NORMAL BEFORE USE. DAILY QC WAS ACCEPTABLE. SAMPLES WERE NOT TESTED USING MANUAL GEL. CUSTOMER HAS DISCUSSED THE SAMPLE RESULTS WITH THEIR BLOOD BANK MEDICAL DIRECTOR. THEY CONCLUDED THAT THE PATIENT MAY BE AN RH MOSAIC AND ISSUE IS SAMPLE RELATED. OCD PERFORMED A REVIEW OF THE BATCH RECORD. SATISFACTORY RESULTS WERE OBSERVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCREPANT RESULTS WITH THE RH TYPING OF A PATIENT. THE PATIENT FIRST TYPED AS RH NEGATIVE AND IS NOW TYPING AS RH POSITIVE. THE PATIENT WAS FIRST TYPED ON (B)(6) 2009 AS TYPE O-NEG. ON 04/11/10, A SAMPLE ON THE PATIENT WAS TESTED AND RESULTED AS RH POSITIVE (1+). A SECOND SAMPLE WAS REQUESTED AND DRAWN AS PER PROTOCOL. THE FIRST SAMPLE WAS REPEATED ON THE PROVUE ALONG WITH THE REDRAW SAMPLE. BOTH SAMPLES RESULTED THE SAME, RH 1+. BOTH SAMPLES WERE THEN TESTED USING TUBE REAGENTS. IMMEDIATE SPIN WAS NEGATIVE AND WEAK D TESTING RESULTED POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS A/B/D MONOCLONAL GROUPING CARD A/B/O & RH TYPE TESTING REAGENT KSZ MICROTYPING SYSTEMS 062409037-04

    Patients

    Seq Age Sex Outcome Treatment
    1