BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS ANTI-D (MONOCLONAL) CARD

    MDR report key: 6037585 · Received October 18, 2016

    Report

    Report Number
    1056600-2016-00096
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    March 15, 2016
    Report Date
    October 17, 2016
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO PERFORMED BATCH REVIEW, COMPLAINT REVIEW BY LOT AND MASTER LOT. ALL RESULTS WERE SATISFACTORY. NO RETAIN TESTING WAS PERFORMED ON MTS ANTI-D (MONOCLONAL) CARD LOT# 061815041-01 SINCE COMPLAINT WAS REPORTED ON 27SEP2016 AND GEL CARD EXPIRED ON 20APR2016. SAMPLE WAS NOT RETURNED TO ORTHO FOR FURTHER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CONTACTED ORTHO ON 27SEP2016 TO REPORT DISCREPANT RESULTS FOR PATIENT RH TESTING. ON(B)(6) 2016, USING PROVUE ANALYZER, CUSTOMER OBTAINED 2+ ON ANTI-D WELL USING A LOT OF ABD/REV GEL CARDS CUSTOMER OBTAINED 2ND SAMPLE, RE-RAN ON PROVUE, 2+ RESULT CONFIRMED. CUSTOMER FOLLOWED UP WITH MANUAL TUBE TESTING FOR WEAK D, AND OBTAINED 1+ USING ANTI-D BIOCLONE REAGENT. HOWEVER, PATIENT HISTORY SHOWED THAT PATIENT WAS TESTED FOR RH TYPE ON (B)(6) 2016 AT THE AFFILIATED REGIONAL LABORATORY, RUN ON PROVUE ANALYZER, AND RH RESULT WAS NEGATIVE. CUSTOMER CONFIRMED THAT PROVUE PRINTOUT SHOWED A WELL GRADING OF ZERO FOR ANTI-D. TESTING WAS DONE ON AN ANTI-D MONOCLONAL GEL CARD LOT# 061815041-01. NO TUBE TESTING WAS PERFORMED FOR WEAK D AS THE WEAK D WAS NOT PICKED UP BY THE PROVUE ON THAT DATE. ISSUE STARTED ON: (B)(6) 2016. FREQUENCY: ISOLATED. MICROTUBES/WELLS OR CELL (DONOR #) AFFECTED: ANTI-D WELL. METHODOLOGY USED: PROVUE ANALYZER. PATTERN OBSERVED: NEGATIVE. REACTION GRADE OBTAINED: NEGATIVE. CUSTOMER HAD NO EXPECTATION AS THIS WAS THE FIRST TIME PATIENT SAMPLE WAS TESTED, HOWEVER, OBTAINED 2+ ON (B)(6) 2016 WHICH PROVIDED DISCREPANT RESULT. TEST REPEATED: YES, TWICE ON (B)(6) 2016 WITH SAME SAMPLE. RESULT OBTAINED BY REPEATING: 2+, WEAK D, RH POS. METHOD USED TO REPEAT: PROVUE ANALYZER AND TUBE TESTING FOR WEAK D. QC PASSED AT BOTH SITES BEFORE TESTING PATIENT SAMPLES. NO TRANSFUSIONS OR PATIENT HARM REPORTED. RESULTS WERE REPORTED OUT TO CLINICIAN BUT HAVE SINCE THEN BEEN CORRECTED. PATIENT IS RH POS. CUSTOMER REPEATED TESTING AFTER OBTAINING DISCREPANT RESULTS, OBTAINED CORRECT PATIENT RH TYPE- POSITIVE. ORTHO INQUIRED ABOUT TESTING PROCEDURES AND REAGENTS USED, AND DOCUMENTED ALL RELEVANT INFORMATION TO ASSIST WITH INVESTIGATION. AN INVESTIGATION WILL BE OPENED INTO THE MATTER. PATIENT IS A FEMALE AND WAS PREGNANT DURING RH TESTING IN (B)(6). PATIENT RECEIVED 300 MICROGRAMS OF RHOGAM AT (B)(6) OF PREGNANCY ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687594 MTS ANTI-D (MONOCLONAL) CARD MTS GEL CARDS - BLOOD GROUPING REAGENTS KSZ MICROTYPING SYSTEMS 061815041-01

    Patients

    Seq Age Sex Outcome Treatment
    1