BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL-P3

    MDR report key: 8644017 · Received May 27, 2019

    Report

    Report Number
    9610824-2019-00026
    Event Type
    Malfunction
    Date Received
    May 27, 2019
    Date of Event
    April 29, 2019
    Report Date
    May 27, 2019
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    UDI-DI
    07611969952397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 OR WEAKENED REACTIONS OF REAGENT RED BLOOD CELL, CELL 1 = P1 FROM BIOTESTCELL-P3. CELL 1=P1 IS DEFINED IN THE ANTIGEN TABLE AS BEING POSITIVE FOR LUA+B+. THE CUSTOMER DID NOT RETURN THE PRODUCT SAMPLE FOR INVESTIGATIONAL TESTING NOR THE PATIENT SAMPLE THAT HAD CAUSED A FALSE NEGATIVE TEST RESULT. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETENTION SAMPLE OF BIOTESTCELL-P3 (CELL 1), LOT: 2913011-00 WITH BIO-RAD`S ANTI-LUA, LOT # 2910080-00. NEGATIVE CONTROLS, A, LUA+B+ PATIENT SAMPLE AND THREE LUA+B+ RED BLOOD CELLS WERE TESTED FOR ANTIGENICITY. ALL POSITIVE REACTIONS WERE COMPARABLE AND CLEARLY POSITIVE (2+ POS. TO 3+ POS.). WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-P3 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437715 REAGENT RED BLOOD CELLS BIOTESTCELL-P3 BIOTESTCELL-P3 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 2913011-00 07611969952397

    Patients

    Seq Age Sex Outcome Treatment
    1