BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL P3

    MDR report key: 5026819 · Received August 25, 2015

    Report

    Report Number
    9610824-2015-00030
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    June 22, 2015
    Report Date
    August 25, 2015
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THAT A PATIENT SAMPLE WITH AN ANTI-KP(A) YIELDED AN UNEXPECTED POSITIVE REACTION WITH SCREENING CELL #3 OF BIOTESTCELL-P 3. SCREENING CELL #3 WAS DECLARED TO BE KP(A) NEGATIVE, BUT THE CUSTOMER SUSPECTED THAT IT MIGHT BE KP(A) POSITIVE. THE CUSTOMER DID NEITHER RETURN THE PATIENT SAMPLE THAT HAD CAUSED A FALSE POSITIVE TEST RESULT NOR THE SUPPOSEDLY DEFECTIVE PRODUCT. AT THE TIME THE CUSTOMER FILED HIS COMPLAINT, THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-P 3 WAS ALREADY EXPIRED. NEVERTHELESS OUR QUALITY CONTROL LABORATORY TESTED CELL #3 OF BIOTESTCELL-P3 WITH ANTI-KP(A) IN THE TUBE TECHNIQUE. CELL #3 SHOWED A CLEAR NEGATIVE REACTION. THE ANTIGEN DETERMINATION OF THE DONOR OF SCREENING CELL #3 WAS REVIEWED. IN ACCORDANCE WITH THE REQUIREMENTS THE KP(A) ANTIGEN WAS TYPED TWICE WITH TWO DIFFERENT ANTISERA. IN BOTH CASES THE DONOR OF CELL #3 WAS TYPED TO BE KP(A) NEGATIVE AND KP(B) POSITIVE. 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
    562329 REAGENT RED BLOOD CELLS BIOTESTCELL P3 BIOTESTCELL P3 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 2519011-00

    Patients

    Seq Age Sex Outcome Treatment
    1