BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD

    MDR report key: 4843852 · Received June 15, 2015

    Report

    Report Number
    1056600-2015-00058
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 16, 2015
    Report Date
    June 15, 2015
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAIN TESTING, BATCH REVIEW, AND COMPLAINT REVIEW BY LOT. ALL RESULTS WERE SATISFACTORY. SAMPLE WAS NOT RETURNED TO OCD FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTING A FALSE POSITIVE REACTION TO THE ANTI-B MICROTUBE TO THE ABD/REV GEL CARDS LOT# 012315037-22. PATIENT WAS TESTED WITH THE LISTED LOT OF CARDS. A FALSE POSITIVE REACTION 3-4+ WAS NOTED IN THE ANTI-B MICROTUBE WITH A SAMPLE THAT HAD A HISTORY OF BLOOD GROUP A. CUSTOMER REPORTS AFFECTED PATIENT RESULTS WERE ACCEPTABLE AFTER TROUBLESHOOTING. CTS CONFIRMED THAT NO INCORRECT OR ERRONEOUS RESULTS HAVE BEEN REPORTED AS A RESULT OF THIS REPORTED CONCERN. DAILY QC TESTING WAS ACCEPTABLE ON DAY OF TESTING. ISSUE OCCURED (B)(6) 2015. ISSUE REPORTED (B)(6) 2015. METHODOLOGY USED: MANUAL GEL. PATTERN OBSERVED: 3-4+ REACTIONS. CUSTOMER WAS EXPECTING: NEGATIVE. TEST REPEATED: YES. RESULT OBTAINED BY REPEATING: EXPECTED NEGATIVE RESULTS. METHOD USED TO REPEAT: MANUAL GEL. CUSTOMER HAS USED 1 1/2 BOXES SO FAR WITHOUT ANY REPORTED CONCERNS WITH THEIR QC OR PATIENT TESTING. CUSTOMER REPORTS THAT CURRENT LOT IS STILL IN USE AND NO ADDITIONAL ISSUES NOTED. ALL GEL CARDS CONFIRMED TO HAVE NORMAL APPEARANCE AND STORED ACCORDING TO THE IFU INDICATIONS (ROOM TEMP). FOILS CONFIRMED TO BE INTACT AND SECURE. SAMPLES COLLECTED IN EDTA TUBES. OCD CONFIRMED THAT THE CUSTOMER'S REPORTED CONCERN IS NOT OBSERVED WITH THEIR QUALITY CONTROL. OCD DISCUSSED PIPETTING TECHNIQUES AND THE IMPORTANCE OF NOT TOUCHING THE MICROTUBES DURING PIPETTING. UPON FOLLOW UP WITH CUSTOMER, CUSTOMER REPORTS THAT CURRENT LOT IS STILL IN USE AND NO ADDITIONAL ISSUES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389163 BLOOD GROUPING REAGENT MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS KSZ MICROTYPING SYSTEMS 012315037-22

    Patients

    Seq Age Sex Outcome Treatment
    1