BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

    MDR report key: 12605635 · Received October 11, 2021

    Report

    Report Number
    9610824-2021-00066
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Date of Event
    September 19, 2021
    Report Date
    October 11, 2021
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    QHT
    UDI-DI
    07611969952380
    PMA / PMN Number
    125207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR COMBINED INITIAL AND FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PATIENT SAMPLE SHOWED A POSITIVE ANTIBODY SCREENING TEST WITH BIOTESTCELL 1&2 ON TANGO INFINITY. ON FURTHER INVESTIGATION THE CUSTOMER WAS ABLE TO IDENTIFY AN ANTI-CW. THEY USED BIOTESTCELL-I11 PLUS AND PANEL CELLS FROM IMMUCOR FOR THE ANTIBODY IDENTIFICATION. THE CUSTOMER WAS CONCERNED BECAUSE BOTH CELLS OF THE AFFECTED BIOTESTCELL 1&2 LOT WERE CW NEGATIVE ACCORDING TO THE PROVIDED ANTIGEN TABLE. BASED ON THEIR TEST RESULTS THE CUSTOMER SUSPECTED A TYPING ERROR IN THE ANTIGEN TABLE OR A MISTYPING OF THE AFFECTED LOT BIOTESTCELL 1&2. THE CUSTOMER DID NOT RETURN THE AFFECTED PRODUCT BIOTESTCELL 1&2 OR THE PATIENT SAMPLE FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF THE SUPPOSEDLY DEFECTIVE LOT. BOTH AFFECTED SCREENING CELLS WERE TESTED WITH SERACLONE ANTI-CW. BOTH SHOWED NEGATIVE RESULTS. ADDITIONALLY, THE RETENTION SAMPLE OF BIOTESTCELL 1&2 WAS TESTED WITH AN ANTI-CW (IGG TYPE) ON TANGO INFINITY. AGAIN, BOTH SCREENING CELLS SHOWED COMPLETELY NEGATIVE RESULTS. THE ANTIGENS OF BOTH DONORS HAD BEEN TESTED, AMONG OTHERS THE CW ANTIGEN IN THE DOUBLE DETERMINATION. BOTH DONORS SHOWED NEGATIVE RESULTS. WITHIN THE FINAL SEROLOGICAL CONTROL OF THE SUPPOSEDLY DEFECTIVE LOT THE RH ANTIGENS WERE ALSO TESTED. ALL TESTS CONFIRMED THAT BOTH DONORS WERE CW NEGATIVE. THE INFORMATION IN THE ANTIGEN TABLE WERE CORRECT. RESULT IMAGES AND LOG FILES OF THE AFFECTED TANGO INFINITY WERE NOT PROVIDED FOR INVESTIGATION. THE LAST PREVENTIVE MAINTENANCE WAS CONDUCTED ON APRIL14, 2021. A FIELD SERVICE ENGINEER WAS NOT ON-SITE BECAUSE THSI COMPLAINT IS NOT RELATED TO A TECHNICAL ISSUE. THE CUSTOMER WAS SUPPORTED BY PHONE CALL. BASED ON THE INVESTIGATION THE COMPLAINT WAS CLASSIFIED AS UNJUSTIFIED. ALL TESTS CONFIRMED THAT THE CW ANTIGEN IS NEGATIVE IN BOTH DONORS. THE INFORMATION IN THE ANTIGEN TABLE PROVIDED WAS CORRECT. A TYPO IN THE ANTIGEN TABLE RESPECTIVELY A MISTYPING OF BOTH DONORS AS SUSPECTED BY CUSTOMER COULD BE EXCLUDED. WE WERE UNABLE TO PROVIDE INFORMATION ON THE SPECIFICITY OF THE IDENTIFIED ANTIBODY BECAUSE THE SAMPLE WAS NOT MADE AVAILABLE TO US. THE CUSTOMER DID NOT PROVIDE ALL REQUESTED INFORMATION BUT INFORMED US THAT THE COMPLAINT COULD BE CLOSED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. FROM INSTRUMENT'S PERSPECTIVE, BASED ON CURRENT INFORMATION THERE IS NO INDICATION FOR AN INSTRUMENT MALFUNCTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507058 REAGENT RED BLOOD CELLS BIOTESTCELL 1&2 BIOTESTCELL 1&2 QHT BIO-RAD MEDICAL DIAGNOSTICS GMBH 9130011-00 07611969952380

    Patients

    Seq Age Sex Outcome Treatment
    1 TANGO INFINITY, SN (B)(4)