BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS DILUENT 2 PLUS

    MDR report key: 1156266 · Received September 4, 2008

    Report

    Report Number
    1056600-2008-00278
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    August 6, 2008
    Report Date
    September 4, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK HOW THE DILUENT BECAME CONTAMINATED. THE CUSTOMER INDICATED THEY OBTAINED ACCEPTABLE RESULTS WHEN THE SAMPLES WERE REPEATED USING THE SAME LOT OF GEL CARDS, AND A NEWLY OPENED DILUENT BOTTLE FROM THE SAME LOT. THE CUSTOMER ALSO INDICATED THAT THE DISPENSER, THAT WAS PREVIOUSLY INVOLVED IN TESTING, WAS NOT USED DURING REPEAT TESTING. THEREFORE, CONTAMINATED DISPENSER MAY HAVE CONTRIBUTED TO THIS INCIDENT. REVIEW OF MANUFACTURING DOCUMENTS INDICATES THAT THIS PRODUCT PASSED ALL RELEASE CRITERIA. THE CUSTOMER DID NOT REPORT OF PARTICULATES OR ANY ABNORMAL APPEARANCE IN THE DILUENT BOTTLE PRIOR TO USE. A COMPLAINT REVIEW INDICATED NO OTHER COMPLAINTS HAVE BEEN LOGGED AGAINST THIS LOT OF DILUENT. INCIDENT IS ISOLATED. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBTAINED FALSE POSITIVE RESULTS WITH THE MTS A/B/D MONOCLONAL, AND REVERSE GROUPING CARD LOT # 101007037-27, WITH 2 PATIENT SAMPLES. THE CUSTOMER INDICATED THE PATIENTS WERE TYPED AS GROUP A POSITIVE, WITH THE ANTI-B AND CONTROL MICROTUBES APPEARING AS WEAKLY POSITIVE REACTIONS. THE CUSTOMER SUSPECTED THE MTS DILUENT 2 PLUS LOT # 012-189 USED IN PREPARATION OF THE CELL SUSPENSIONS WAS CONTAMINATED. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS DILUENT 2 PLUS RED BLOOD CELL DILUENT KSG MICRO TYPING SYSTEMS, INC. NA 012-189

    Patients

    Seq Age Sex Outcome Treatment
    1