BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTYPE S RH+K TYPE

    MDR report key: 7453912 · Received April 24, 2018

    Report

    Report Number
    9610824-2018-00021
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    March 20, 2018
    Report Date
    April 24, 2018
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969951291
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT SAMPLE SHOWED A FALSE POSITIVE ANTIBODY SCREENING REACTION WHEN TESTED WITH ERYTYPE S RH+K TYPE ON TANGO INFINITY WHEREAS A SAMPLE OF THE PATIENT TESTED WITH ERYTYPE S RH+ K-TYPE ON MARCH, 09 YIELDED NEGATIVE TEST RESULTS. BECAUSE OF THE POSITIVE TEST RESULTS ON ERYTYPE S THE CUSTOMER TYPED THE PATIENT SAMPLE FOR E AND C ANTIGEN BY USING THE TUBE TECHNIQUE AND YIELDED NEGATIVE TEST RESULTS. DUE TO THE CURRENT POSITIVE ANTIBODY SCREENING TEST THE CUSTOMER ASSUMED THAT THE PATIENT HAS BEEN TRANSFUSED. THE CUSTOMER DID RETURN THE PATIENT SAMPLE THAT HAD CAUSED A FALSE POSITIVE REACTION AN DID RETURN THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING. WHEN OUR QUALITY CONTROL RECEIVED THE COMPLAINT SAMPLE THE SHELF LIFE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS ALREADY EXPIRED. NEVERTHELESS OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE COMPLAINT PRODUCT OF ERYTYPE RH+K TYPE ON TANGO INFINITY. THE PATIENT SAMPLE YIELDED A WEAK POSITIVE REACTION WITH ANTI-C ON ERYTYPE S RH+K TYPE. THE PATIENT SAMPLE WAS ALSO TESTED WITH OUR RETENTION SAMPLE AND THE CURRENT LOT OF ERYTYPE S RH+K TYPE. THE PATIENT SAMPLE SHOWED A WEAK POSITIVE REACTION WITH ANTI-C OF BOTH ERYTYPE S RH + K TYPE TESTS. IN ADDITION THE PATIENT SAMPLE WAS TESTED FOR RH PHENOTYPE BY USING THE GEL CARD METHOD. THE PATIENT SAMPLE YIELDED POSITIVE REACTIONS (DOUBLE POPULATION) WITH ANTI-C AND ANTI-E. ALL POSITIVE REACTIONS OBSERVED BY THE CUSTOMER MUST BE INTERPRETED AS CORRECT POSITIVE REACTIONS DUE TO THE TRANSFUSION OF THE PATIENT. THE DETECTION OF ANTI-E AND ANTI-C IN THE PATIENT SAMPLE ARE A STRONG INDICATOR THAT THE PATIENT HAS BEEN TRANSFUSED WITH E AND C POSITIVE RED BLOOD CELLS. THESE TRANSFUSED RED BLOOD CELLS WERE DETECTED WITH THE SENSITIVE METHOD OF ERYTYPE ON TANGO INFINITY. TESTING OF DIFFERENT DONOR SAMPLES WITH THE SUPPOSEDLY DEFECTIVE PRODUCT (WITHIN ITS SHELFLIFE) SHOWED THAT ALL POSITIVE AND NEGATIVE RESULTS WERE CORRECT AND WE DID NOT OBSERVE ANY FALSE POSITIVE RESULTS. THE TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF ERYTYPE RH+K TYPE FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO INFINITY WAS CHECKED BY OUR FIELD SERVICE ENGINEERS WITH NO INDICATION FOR A MALFUNCTION. THE INSTRUMENT IS CONFIRMED TO RUN WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295995 ERYTYPE S RH+K TYPE ERYTYPE S RH+K TYPE KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8640050 07611969951291

    Patients

    Seq Age Sex Outcome Treatment
    1