BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO CLINICAL DIAGNOSTICS

    MDR report key: 6746573 · Received July 27, 2017

    Report

    Report Number
    1056600-2017-00067
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    July 11, 2017
    Report Date
    July 27, 2017
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO DIFFERENCES IN THE SPECIFIC GRAVITY OF DONOR CELLS VS. AUTOLOGOUS (PATIENT) RED CELLS, UNEXPECTED RESULTS MAY POTENTIALLY BE OBTAINED WHEN BLOOD SAMPLES DRAWN FROM RECENTLY TRANSFUSED PATIENTS ARE TESTED BY A VARIETY OF TEST METHODS USED IN IMMUNOHEMATOLOGY, INCLUDING ANTIGEN TYPING USING ID-MICRO TYPING SYSTEM¿ (MTS) GEL CARDS. ¿FOLLOWING CENTRIFUGATION OF A FRESHLY COLLECTED PATIENT SAMPLE DRAWN FROM A RECENTLY TRANSFUSED PATIENT, THE POTENTIAL EXISTS FOR THE DONOR¿S TRANSFUSED RED CELLS, WHICH ARE DENSER AND HEAVIER, TO CONCENTRATE AT THE BOTTOM OF THE SAMPLE TUBE IN A LAYER BELOW THE PATIENT¿S OWN RED CELLS, WHICH ARE LESS DENSE AND LIGHTER. IF THE CELL SUSPENSION USED FOR TESTING CONTAINS A MAJORITY OF TRANSFUSED DONOR CELLS, UNEXPECTED PATIENT RESULTS COULD BE OBSERVED DUE TO THE PATIENT CELLS BEING AN ABSENT OR MINOR POPULATION IN THE PREPARED CELL SUSPENSION. THE UNEXPECTED PATIENT RESULT COULD BE A RESULT ASSOCIATED WITH THE TRANSFUSED DONOR CELLS, OR IT COULD BE DUE TO A MIX OF PATIENT AND DONOR CELL POPULATIONS.¿ THE INVESTIGATION DETERMINED THAT THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS SAMPLE RELATED DUE TO PRIOR TRANSFUSION.

    Description of Event or Problem · 1

    ORTHO FE CALLED ORTHO CARE TO REPORT FALSE NEGATIVE RESULTS IN FORWARD A MICRO COLUMN OF MTS ABD/ABD CARD WHERE PROVUE RESULTED O POS WITH A SINGLE PATIENT SAMPLE. CUSTOMER REPORTS PATIENT HAS PAST MEDICAL HISTORY OF A POS SO FURTHER INVESTIGATION WAS NEEDED BEFORE RESULTS RELEASED. CUSTOMER REPORTS NO PATIENT HARM OCCURRED TO DUE TO THIS EVENT. CUSTOMER REPORTS; PATIENT RECENTLY TRANSFUSED WITH O POS UNITS, QUANTITY AND DATE OF TRANSFUSION WERE NOT PROVIDED. NO PATIENT HARM DUE TO THIS EVENT OCCURING ACCORDING TO CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529503 ORTHO CLINICAL DIAGNOSTICS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1