BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5851800 · Received August 5, 2016

    Report

    Report Number
    1056600-2016-00063
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    May 27, 2016
    Report Date
    August 5, 2016
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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

    REPORT 1 OF 3. CUSTOMER REPORTING 3 SEPARATE EVENTS OF FALSE POSITIVE RESULTS WITH THE MTS ABD/ABD CARDS LOT 100215053-05 EXP 10/5/16. ACCORDING TO CUSTOMER FIRST INCIDENT OF FALSE POSITIVE OCCURRED DURING DONOR RETYPE ON (B)(6) 2016. CUSTOMER CLAIMED DONOR UNIT LABELED AS GROUP O, RH NEGATIVE, WAS RETYPE AS FACILITY WITH POSITIVE REACTION WITH ANTI-B MICROWELL (1+) AND 2+ WITH ANTI-D MICROWELL. CUSTOMER STATED BECAUSE OF DISCREPANCY, UNIT WAS RETURN TO DONOR CENTER. CUSTOMER FURTHER ADDED FACILITY HAD A SECOND INCIDENT OF ABO DISCREPANCY, BUT NO DETAILS PROVIDED TO ORTHO. CUSTOMER ALSO CLAIMED ON (B)(6) 2016, THIRD INCIDENT OCCURRED DURING RETYPING OF DONOR UNIT OF GROUP A, RH POSITIVE, AND CUSTOMER GOT POSITIVE REACTION IN THE ANTI-B MICROWELL ( 4+). AGAIN BECAUSE OF DISCREPANCY, CUSTOMER REPEATED TESTING USING TUBE METHOD AND DONOR UNIT WAS CONFIRMED AS GROUP A, RH POSITIVE. CUSTOMER STATED GEL CARDS LOOK FINE, AND ALL QC TESTING WERE PERFORMED AND ACCEPTABLE. STATED MTS DILUENT WAS OPENED ON 6/3/16 AND IS PASSING ALL VISUAL TESTING. CUSTOMER STATED UPON REVIEW OF GEL CARDS, THAT GEL CARDS APPEARANCE WERE OK. SAW NO SIGNS OF LOW LIQUID LEVELS NOR DRYNESS. ISSUE STARTED ON: (B)(6) 2016; REPORTED (B)(6) 2016. FREQUENCY: 3 PATIENTS. METHODOLOGY USED: MANUAL GEL. CARDS /CASSETTES/ STORAGE CONDITION TEMPERATURE: ALL CARDS STORED APPROPRIATELY. VISUAL APPEARANCE BEFORE USE: ALL GEL CARDS ARE PASSING VISUAL INSPECTION. ORTHO REVIEW PIPETTING TECHNIQUES AND POSSIBLE CARRY OVER DURING TESTING. CANNOT EXPLAINED WHAT COULD HAVE HAPPENED WITH INITIAL TESTING ON (B)(6) 2016. ORTHO RECOMMEND CUSTOMER REPEAT TESTING OF DONOR UNIT AND WILL FOLLOW UP WITH CUSTOMER. HAD ACCOUNT INSPECT CARDS AND THAT STATED CARDS APPEARANCE OK. ORTHO PROPOSED CORRECTIVE ACTION TO REVIEW PIPETTING STEPS; AND ORTHO WILL FOLLOW UP WITH CUSTOMER ON STATUS OF REPEAT. ORTHO FOLLOWED UP WITH CUSTOMER AND WAS TOLD WHEN TESTING WAS REPEATED USING THE SAME LOT # OF GEL CARDS, THE RESULTS WERE IN AGREEMENT WITH DONOR TYPE. CUSTOMER CANNOT EXPLAINED WHAT COULD HAVE CAUSE THE FALSE POSITIVE REACTION IN THE FIRST INCIDENT. CUSTOMER AGREE TO MONITOR AND WILL CONTACT ORTHO IF ANY ADDITIONAL EVENT OCCUR. DOES NOT NEED ANY FOLLOW-UP FROM ORTHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503759 BLOOD GROUPING REAGENT MTS¿ A/B/D MONOCLONAL GROUPING CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS KSZ MICROTYPING SYSTEMS 100215053-05

    Patients

    Seq Age Sex Outcome Treatment
    1