BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1,2

    MDR report key: 5546541 · Received April 5, 2016

    Report

    Report Number
    9610824-2016-00014
    Event Type
    Malfunction
    Date Received
    April 5, 2016
    Report Date
    April 5, 2016
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 ANTIBODIES OF THE QUOTIENT'S COMPETENCY KIT WERE MISSED WHEN TESTING WITH BIOTESTCELL 1&2 IN THE TUBE TECHNIQUE. THE CUSTOMER REPORTED THAT FOUR SAMPLES OF THE COMPETENCY KIT WERE TESTED AND SHOWED POSITIVE RESULTS IN THE ORTHO GEL SYSTEM, BUT ONLY ONE SAMPLE SHOWED A POSITIVE REACTION IN THE TUBE TECHNIQUE WITH BIOTESTCELL 1&2. FURTHERMORE THE CUSTOMER REPORTED THAT ALSO ANTIBODIES OF TWO PATIENT SAMPLES WERE MISSED IN THE TUBE TECHNIQUE, BUT DETECTED IN THE GEL SYSTEM. THE CUSTOMER DID NEITHER RETURN THE PATIENT SAMPLES AND THE QUOTIENT'S COMPETENCY KIT THAT HAD CAUSED FALSE NEGATIVES NOR THE SUPPOSEDLY DEFECTIVE PRODUCT WAS SENT FOR INVESTIGATIONAL TESTING. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THEIR RETAINED SAMPLE OF BIOTESTCELL 1&2 WITH DIFFERENT ANTIBODIES OF THE RHESUS-, THE KELL-, THE KIDD AND THE DUFFY-SYSTEM IN THE TUBE TECHNIQUE. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTION. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THAT THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL 1&2 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
    204996 REAGENT RED BLOOD CELLS BIOTESTCELL 1,2 BIOTESTCELL 1,2 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8603021-00

    Patients

    Seq Age Sex Outcome Treatment
    1