BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL I11

    MDR report key: 2680154 · Received August 3, 2012

    Report

    Report Number
    9610824-2012-00121
    Event Type
    Malfunction
    Date Received
    August 3, 2012
    Date of Event
    July 6, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS OF A PATIENT SAMPLE WITH BIOTESTCELL-I11 IN THE ORTHO GEL CARD. THE SAMPLE THAT HAD CAUSED THE POSITIVE REACTIONS WAS SENT TO US FOR INVESTIGATIONAL TESTING, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. THEREFORE OUR QUALITY CONTROL LABORATORY TESTED THE PATIENT SAMPLE WITH THE RETAINED SAMPLE OF BIOTESTCELL-I11 AND COULD CONFIRM THE CUSTOMER'S POSITIVE REACTIONS. FURTHER TESTINGS YIELDED IN IDENTIFICATION OF A COLD REACTING ANTIBODY AND ANTIBODIES OF THE HLA (HUMAN LEUCOCYTE ANTIGEN) SYSTEM. FURTHERMORE THE RETAINED BIOTESTCELL-I11 SAMPLE WAS TESTED WITH DIFFERENT POSITIVE AND NEGATIVE SAMPLES. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF BIOTESTCELL-I11 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNEXPECTED POSITIVE REACTIONS OF A PATIENT SAMPLE WITH BIOTESTCELL-I11. THE SAMPLE THAT HAD CAUSED POSITIVE REACTIONS WAS SENT TO US FOR QUALITY CONTROL, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT WAS RETURNED. TESTING IN OUR QUALITY CONTROL LABORATORY IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REAGENT RED BLOOD CELLS BIOTESTCELL I11 BIOTESTCELL I-11 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8225011

    Patients

    Seq Age Sex Outcome Treatment
    1