BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL-I11

    MDR report key: 9415237 · Received December 5, 2019

    Report

    Report Number
    9610824-2019-00078
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 5, 2019
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969952434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULT OF CELL #4 OF BIOTESTCELL-I11 WITH ANTI-LE(B) REAGENTS. BECAUSE CELL #4 (DONOR NO. 103355) IS LISTED AS LE(B) POSITIVE IN THE ANTIGEN PROFILE WORKSHEET, THE CUSTOMER ASSUMED THAT THIS WAS LIKELY A PRINTING ERROR ON THE WORKSHEET. THE CUSTOMER RETURNED NEITHER THE SUPPOSEDLY DEFECTIVE PRODUCT FOR INVESTIGATIONAL TESTING NOR THE ANTI-LE(B) REAGENTS. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED CELL #4 OF THEIR BIOTESTCELL-I11 RETENTION SAMPLE WITH THE BLOOD GROUPING REAGENT SERACLONE ANTI-LE(B) AND GOT ONLY A +/- REACTION. THIS IS A QUESTIONABLE RESULT AND NOT A CLEAR POSITIVE REACTION. FURTHER TESTS CONFIRMED THAT THE SAMPLE OF CELL #4 DOES NOT ALWAYS GIVE CLEARLY POSITIVE RESULTS WITH ANTI-LE(B) REAGENTS. BASED ON THE TEST RESULTS THE COMPLAINT WAS CONFIRMED. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. BUT BASED ON THE CONFIRMED COMPLAINT A DEVIATION WAS INITIATED AND THE DONOR WAS BLOCKED. NO FURTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED. THERE IS NO RISK FOR PATIENTS. ANTI-LE(B) ANTIBODIES BELONG TO THE GROUP OF IGM'S, ARE THEREFORE NOT CLINICALLY RELEVANT AND DO NOT LEAD TO HEMOLYTIC TRANSFUSION REACTIONS. IGM ANTIBODIES ARE NOT PLACENTAL AND DO NOT DAMAGE THE FETUS OR LEAD TO MHN (MORBUS HÄMOLYTICUS-NEONATORUM) IN THE NEWBORN. BECAUSE OTHER CELLS IN BIOTESTCELL- I11 ARE LE(B) POSITIVE, AN ANTI-LE(B) WILL BE DETECTED BUT DETECTION MIGHT BE DELAYED BECAUSE OF THE UNEXPECTED NEGATIVE REACTION IN CELL #4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215742 REAGENT RED BLOOD CELLS BIOTESTCELL-I11 BIOTESTCELL-I11 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8941011-00 07611969952434

    Patients

    Seq Age Sex Outcome Treatment
    1