BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GROUPING REAGENT MTS¿ A/B/D MONOCLONAL GROUPING CARD

    MDR report key: 6636549 · Received June 13, 2017

    Report

    Report Number
    1056600-2017-00054
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    May 19, 2017
    Report Date
    June 12, 2017
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 CONTACTED TSC TO REPORT FALSE NEGATIVE RESULT ON PROVUE WITH CORD BLOOD PATIENT SAMPLE ON FORWARD TYPING, ANTI-A WELL. CUSTOMER REPORTING THAT AFTER OBTAINING AN INITIAL A WEAK POS RESULT, SHE REPEATED SAMPLE ON PROVUE A SECOND TIME, IN WHICH SHE OBTAINED O POSITIVE ABO TYPING RESULT. CUSTOMER TESTING ON PROVUE USING ABD MONOCLONAL GEL CARD LOT# 120216053-03 EXP. OCT 17 2017. CUSTOMER THEN TESTED SAMPLE USING TUBE METHOD REAGENTS IN WHICH PATIENT TYPED A POSITIVE, WITH THE ANTI-A RESULT YIELDING 2+ REACTION. ISSUE STARTED ON: (B)(6) 2017. SAMPLE ID: CORD BLOOD PATIENT SAMPLE MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED: ANTI-A WELL METHODOLOGY USED: PROVUE. PATTERN OBSERVED: FALSE NEGATIVE. REACTION GRADE OBTAINED: NEGATIVE FOR FORWARD TYPE. CUSTOMER WAS EXPECTING: REACTION IN ANTI-A MICROTUBE. TEST REPEATED: YES . RESULT OBTAINED BY REPEATING: OBTAINED A POSITIVE ABO TYPE IN TUBE METHOD. METHOD USED TO REPEAT: TUBE. ABO BLOOD TYPE OF MOTHER IS O POSITIVE. CUSTOMER CENTRIFUGES CORD BLOOD SAMPLE, REMOVES PLASMA, WASHES RED CELLS ONCE BEFORE TESTING. QC FOR ALL REAGENTS OK PRIOR TO TESTING PATIENT SAMPLE. CUSTOMER USING ALBAQ LOT# V182287 EXP. 6/20/17 FOR QC. UPON REVIEWING OF PROVUE RESULTS, ON THE FIRST TIME TESTED ON THE PROVUE, PROVUE RESULT WAS ORIGINALLY A ? MARK ON ANTI-A WELL, CUSTOMER THEN MODIFIED RESULT TO NEGATIVE AFTER MANUAL READING OF GEL CARD. THIS APPEARS TO BE A USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419533 BLOOD GROUPING REAGENT MTS¿ A/B/D MONOCLONAL GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS KSZ MICROTYPING SYSTEMS 120216053-03

    Patients

    Seq Age Sex Outcome Treatment
    1