BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS DILUENT 2 PLUS

    MDR report key: 4802601 · Received May 28, 2015

    Report

    Report Number
    1056600-2015-00048
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    April 26, 2015
    Report Date
    May 28, 2015
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD PERFORMED RETAIN TESTING, BATCH REVIEW AND COMPLAINT REVIEW BY LOT. ALL RESULTS WERE SATISFACTORY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED ONE PATIENT SAMPLE THAT FAILED TO REACT WITH ANY CELLS (REAGENT OR UNITS) WHERE THEY MADE UP THEIR OWN 0.8% RED CELLS USING MTS DILUENT 2 PLUS LOT MDP107. SAMPLE TESTED ON (B)(6) 2015. INITIALLY ACCOUNT PERFORMED MANUAL TESTING IN GEL WITH BOTH ORTHO SCREENS AND PANELS. ACCOUNT SAW REACTIVITY BUT COULD NOT IDENTIFY ANY SPECIFIC ANTIBODIES. ACCOUNT DILUTED 3% SURGISCREEN TO 0.8% AND TESTED IN GEL. NO REACTIVITY WAS NOTED. THEY ALSO DILUTED AN IMMUCOR PANEL - NO REACTIVITY NOTED. ACCOUNT CROSS MATCHED UNITS IN GEL; RESULTS WERE ALL COMPATIBLE. ONE UNIT WAS TRANSFUSED WITH NO PROBLEM. ACCOUNT SENT SAMPLE TO THE ARC FOR TESTING. ARC ALSO SAW REACTIVITY IN GEL THAT THEY COULD NOT IDENTIFY. ARC ALSO DILUTED IMMUCOR CELLS AND SAW NO REACTIVITY. HOWEVER, ARC PERFORMED A PEG SCREEN AND PANEL AND IDENTIFIED ANTI-JKA AND ANTI-FYA. THE UNIT THAT WAS TRANSFUSED WAS JKA AND FYA POSITIVE BUT PATIENT DID NOT EXPERIENCE ANY TYPE OF REACTION. UNIT WAS GIVEN ON (B)(6) 2016 FOLLOWED BY 2 UNITS OF FRESH FROZEN PLASMA FOLLOWED BY ANOTHER UNIT THAT WAS JKA AND FYA NEGATIVE. ACCOUNT FOLLOWED THE PATIENT UNTIL SHE WAS DISCHARGED ON (B)(6) 2015. NO POSITIVE DAT WAS DEVELOPED; NO SIGNS OF HEMOLYSIS WERE SHOWN. PATIENT IS A (B)(6) FEMALE WITH CHRONIC KIDNEY DISEASE. ACCOUNT IS NOT ALLEGING ANY PROBLEM WITH ORTHO CELLS, THEY FEEL THE PROBLEM IS THE MTS DILUENT 2 PLUS. INCUBATION TIME (FOR MANUAL TEST ONLY): 15 MINUTES. SAMPLE TYPE: EDTA PLASMA. DAILY QC WAS PERFORMED AND FOUND TO BE ACCEPTABLE. ALL REAGENTS WERE STORED APPROPRIATELY AND HAD NORMAL APPEARANCE PRIOR TO USE. OCD INFORMED ACCOUNT THAT THEY SHOULD BE USING MTS DILUENT 2 FOR IGG TESTING RATHER THAN MTS DILUENT 2 PLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347052 MTS DILUENT 2 PLUS DILUENT KSZ MICROTYPING SYSTEMS MDP107

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR