BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ANTI-A, B (MURINE MONOCLONAL BLEND) CARD

    MDR report key: 6669966 · Received June 27, 2017

    Report

    Report Number
    1056600-2017-00061
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    June 7, 2017
    Report Date
    June 27, 2017
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTING ONE EVENT OF FALSE POSITIVE 2+ REACTION IN A DONOR UNIT MARKED AS GROUP O, RH POSITIVE USING MTS A,B CARD LOT # 012317038-01 EXP 11/9/2017. ACCORDING TO CUSTOMER, SEGMENT FROM THE DONOR BLOOD BAG WAS TESTED ON ORTHO PROVUE (1ST PROVUE-THIS EVENT) WITH THE MTS ANTI-A,B CARD. THE RESULT WAS 2+ POSITIVE, WHEN THE EXPECTED RESULT WAS NEGATIVE. TESTING WAS REPEATED MANUAL TUBE METHOD USING COMPETITOR'S ANTISERA, ANTI-A,B AND THE RESULT WAS NEGATIVE. FURTHER TESTING WAS PERFORMED USING A SECOND SEGMENT PULLED FROM THE BAG AND RUN ON SECOND ORTHO PROVUE (2ND PROVUE-SEE MXP 1913060) AND THE RESULT WAS 1+ POSITIVE AND WHEN MANUALLY TESTED, THE RESULT WAS NEGATIVE. TESTING AGAIN WAS PERFORMED WITH SAME GEL CARD LOT #. CUSTOMER ALSO TESTED THE SAME SEGMENT AND PERFORMED AN ABO/RH RECHECK (ANTI A, ANTI-B, AND ANTI-D) ON THE PROVUE AND THE RESULT WAS ANTI-A= NEGATIVE, ANTI-B= NEGATIVE, AND ANTI-D= 4+ POSITIVE. THIS WAS THE EXPECTED RESULT FOR A O POSITIVE DONOR UNIT. CUSTOMER ALSO RETESTED AN ALIQUOT OF BLOOD STRAIGHT FROM THE BLOOD DONOR BAG AND TESTED ON PROVUE AND THE ANTI-A,B WAS STILL 2+. THE QC FOR THE DAY PASSED FOR THE ANTI-A,B CARDS ON BOTH PROVUES. PLEASE SEE THE ATTACHED IMAGES OF THE ANTI-A,B CARD. ISSUE STARTED ON: NA; REPORTED (B)(6) 2017. FREQUENCY: ONE DONOR UNIT. METHODOLOGY USED: PROVUE AND TUBE METHOD. REACTION GRADE OBTAINED: 1+ AND 2+. CUSTOMER WAS EXPECTING: NEGATIVE. TEST REPEATED: YES. RESULT OBTAINED BY REPEATING: NEGATIVE USING TUBE METHOD. OTHER REAGENT: MTS DILUENT 2 PLUS USED FOR FORWARD GROUPING LOT NUMBER: NOT PROVIDED. QC TYPE: ALL QC TESTING PASSED WITH ALBAQ QC LOT #: NOT PROVIDED . TSC SENDING DIFFERENT LOT # FOR TROUBLESHOOTING. EDTA. REAGENT/PROTOCOL-HANDLING (REAGENT, CARDS, CASSETTES): VISUALLY INSPECTED BY END USER PRIOR TO USE AND ALSO PASSED INSPECTION BY THE ORTHO PROVUE ANALYZER. CARDS /CASSETTES/ STORAGE CONDITION TEMPERATURE: AS PER IFU. VISUAL APPEARANCE BEFORE USE: ACCEPTABLE. REAGENT RED BLOOD CELL STORAGE AND HANDLING: AS PER IFU.. -EMAIL FROM CUSTOMER STATING WITH REPEAT TESTING USING THE NEW LOT # OF MTS A.B MONO GEL CARDS( LOT # NOT PROVIDED), STILL GETTING POSITIVE REACTIONS WITH GROUP O DONOR UNIT. CUSTOMER INDICATED ISSUE MIGHT BE RELATED TO DONOR UNIT AND WILL BE IN CONTACTED WITH BLOOD SUPPLIER TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452234 MTS ANTI-A, B (MURINE MONOCLONAL BLEND) CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS KSZ MICROTYPING SYSTEMS 012317038-01

    Patients

    Seq Age Sex Outcome Treatment
    1