BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 3

    MDR report key: 2944907 · Received February 6, 2013

    Report

    Report Number
    9610824-2013-00007
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 3, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS OUR INITIAL REPORT ON THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THIS IS OUR FINAL REPORT ON THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ONE FALSE POSITIVE ANTIBODY SCREENING TEST WITH CELL #1 AND #2 OF BIOTESTCELL 3. THE CUSTOMER HAS NEITHER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE POSITIVE TEST RESULT. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE OF BIOTESTCELL 3 WITH DIFFERENT SAMPLES AND CONTROLS. 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 3 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. EVALUATION OF THE AFFECTED TANGO OPTIMO'S FIELD SERVICE REPORT IS STILL ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ONE FALSE POSITIVE ANTIBODY SCREENING TEST WITH CELL #1 AND #2 OF BIOTESTCELL 3. THE CUSTOMER HAS NEITHER RETURNED THE SUPPOSEDLY DEFECTIVE PRODUCT NOR THE PATIENT SAMPLE THAT HAD CAUSED THE FALSE POSITIVE TEST RESULT. THEREFORE, OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE OF BIOTESTCELL 3 WITH DIFFERENT SAMPLES AND CONTROLS. 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 3 FUNCTIONS CORRECTLY. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE ALLEGEDLY DEFECTIVE LOT. THE AFFECTED TANGO OPTIMO WAS THOROUGHLY CHECKED WITH NO INDICATION FOR ANY PROBLEMS OR MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51195 REAGENT RED BLOOD CELLS BIOTESTCELL 3 BIOTESTCELL 3 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8247011

    Patients

    Seq Age Sex Outcome Treatment
    1 MLB2, LOT 8209060| TANGO OPTIMO, # 9142400268| MLB2, LOT 8209060| AHG, LOT 8221110-00| TANGO OPTIMO, # 9142400268| AHG, LOT 8221110-00