BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO VISION ID-MTS

    MDR report key: 10570618 · Received September 22, 2020

    Report

    Report Number
    2250051-2020-00047
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 22, 2020
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT HAS BEEN INVESTIGATED AND DETERMINED THAT THE MOST LIKELY ROOT CAUSE OF THIS EVENT WAS SAMPLE-RELATED, DUE TO THE PATIENT'S RECENT TRANSFUSION OF 2 UNITS OF RH NEGATIVE BLOOD. PATIENT HAS A HISTORY IS ANOTHER HOSPITAL OF O RH POSITIVE AND TUBE TESTING AT CUSTOMER SITE CONFIRMED TYPE O RH POSITIVE RESULTS. PATIENT WAS TRANSFUSED COMPATIBLE TYPE O RH NEGATIVE BLOOD. DUE TO THE HIGHER DENSITY OF THE TRANSFUSED CELLS, THE VISION ASPIRATED THE RH NEGATIVE TRANSFUSED CELLS FROM THE BOTTOM OF THE TUBE (TSC REFERRED CUSTOMER TO CUSTOMER LETTER CL2015-187 AUTOLOGOUS BLOOD LETTER). GOOD LABORATORY PRACTICES REQUIRED TWO METHODOLOGIES OF BLOOD TYPING IDENTIFICATION IF NO PATIENT HISTORY IS AVAILABLE. THERE WAS NO REPORT OF PATIENT HARM. A ONE YEAR LOOKBACK WAS PERFORMED FOR RELATED COMPLAINTS IN THE WORLDWIDE DATA BASE. NO RELATED TREND WAS IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTING ONE EVENT OF FALSE NEGATIVE REACTION TO THE ANTI-D MICROWELL TO THE MTS ABD/REV GEL CARD TO A PATIENT LATER CONFIRMED TO BE GROUP O, RH POS. INCIDENT OCCURRED ON (B)(6) 2020: REPORTED ON (B)(6) 2020 ACCORDING TO CUSTOMER, PATIENT WAS ORIGINALLY TESTED AT (B)(6) HOSPITAL ON (B)(6) 2020 AS O POSITIVE 4+ ON THEIR VISION AND BLOOD TYPE WAS CONFIRMED USING TUBE METHOD AS GROUP O, RH POSITIVE. PATIENT ARRIVED AT CURRENT FACILITY ON (B)(6) 2020, AND SAMPLE WAS TESTED ON VISION AND SAW BLOOD TYPE AS GROUP O, RH NEGATIVE. SPECIMEN WAS THEN TESTED AT THE BENCH AND WITH TUBE METHOD, SHOWED A 4+ POSITIVE FOR THE ANTI-D. TESTING WAS REPEATED AGAIN ON VISION AND STILL SHOWED RH NEGATIVE. ADDITIONAL TESTING WAS THEN PERFORMED ON SPECIMEN WITH THE ABD GROUPING CARD BY ALIQUOTING SMALL AMOUNT OF PACKED CELLS AND SAMPLE REACTED AS RH POSITIVE. NEXT CUSTOMER ALIQUOTED THE SPECIMEN INTO A SMALLER TUBE, SPUN IT AND RETESTED ON THE VISION WITH THE MTS ABD AND REVERSE CARD AND SAW RH POSITIVE RESULT FOR ANTI-D. ACCORDING TO CUSTOMER, IMAGES AND CELL LEVELS WERE REVIEWED AND ALL LOOKED OK, NOTHING DIFFERENT WAS NOTED. DURING ADDITIONAL INVESTIGATION, IT WAS DETERMINED THAT PATIENT WAS TRANSFUSED WITH TWO UNITS OF GROUP O,RH NEGATIVE PACKED RED CELLS ON (B)(6) 2020. TSC DISCUSSED 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. ALSO REVIEWED WITH CUSTOMER THAT "UNDER LIMITATION OF VISION REF GUIDE" THAT: WHEN A SAMPLE IS COLLECTED FROM A RECENTLY TRANSFUSED PATIENT, THE POTENTIAL EXISTS FOR THE TRANSFUSED RED CELLS TO CONCENTRATE AFTER CENTRIFUGATION AT THE BOTTOM OF THE SAMPLE BELOW THEIR AUTOLOGOUS CELLS. THE PROBE ASPIRATES FROM THE BOTTOM OF THE TUBE WHERE THE TRANSFUSED CELLS GENERALLY CONCENTRATE WHICH MAY LEAD TO AN UNEXPECTED RESULT. CUSTOMER EXPRESSED UNDERSTANDING OF POSSIBLE CAUSED OF THE FALSE NEGATIVE REACTIONS. SHE WAS SATISFIED WITH DISCUSSION AND DOES NOT BELIEVE THE ISSUE WAS EQUIPMENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035430 ORTHO VISION ID-MTS AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ ORTHO CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1