BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAGENT RED BLOOD CELLS BIOTESTCELL 1&2

    MDR report key: 3191981 · Received June 27, 2013

    Report

    Report Number
    9610824-2013-00063
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 31, 2013
    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 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 COMPLAINED THAT A QMPLS PROFICIENCY SAMPLE WAS NOT INTERPRETED PROPERLY BY TANGO OPTIMO. TANGO OPTIMO INTERPRETED THE RESULT AS NEGATIVE, WHEN VISUALLY SOME GRANULARITY AROUND THE CELL BUTTON COULD BE SEEN AND THEREFORE THE RESULT WAS MANUALLY EDITED TO +/-. THE ANTIBODY PRESENT IN THE PROFICIENCY SAMPLE IS JK(A). THE SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT WAS SENT TO US FOR INVESTIGATIONAL TESTING, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT HAS BEEN RETURNED. BECAUSE THE VIAL CONTAINING THE SAMPLE HAD NOT BEEN CLOSED PROPERLY THE SAMPLE HAD FULLY DRAINED OFF. THEREFORE A TESTING OF THE SAMPLE WAS NOT POSSIBLE. WE INFORMED THE CUSTOMER ACCORDINGLY AND REQUESTED ANOTHER SAMPLE. WE ARE STILL WAITING FOR THIS SAMPLE. OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE OF BIOTESTCELL 1&2 WITH DIFFERENT SAMPLES AND CONTROLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED 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.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT A QMPLS PROFICIENCY SAMPLE WAS NOT INTERPRETED PROPERLY BY TANGO OPTIMO. TANGO OPTIMO INTERPRETED THE RESULT AS NEGATIVE, WHEN VISUALLY SOME GRANULARITY AROUND THE CELL BUTTON COULD BE SEEN AND THEREFORE THE RESULT WAS MANUALLY EDITED TO +/-. THE ANTIBODY PRESENT IN THE PROFICIENCY SAMPLE IS JK(A). THE SAMPLE THAT HAD CAUSED THE FALSE NEGATIVE TEST RESULT WAS SENT TO US FOR INVESTIGATIONAL TESTING, BUT NONE OF THE SUPPOSEDLY DEFECTIVE PRODUCT HAS BEEN RETURNED. OUR QUALITY CONTROL LABORATORY TESTED THE RETAINED SAMPLE OF BIOTEST CELL 1&2 WITH DIFFERENT SAMPLES AND CONTROLS. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE NEGATIVE REACTIONS. TESTING BY OUR QUALITY CONTROL LABORATORY CONFIRMED THE ALLEGEDLY DEFECTIVE LOT OF BIOTEST CELL 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. THERE IS NO INDICATION FOR A MALFUNCTION OF THE AFFECTED TANGO OPTIMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292842 REAGENT RED BLOOD CELLS BIOTESTCELL 1&2 BIOTESTCELL 1&2 KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH 8319021-00

    Patients

    Seq Age Sex Outcome Treatment
    1 TANGO OPTIMO, # (B)(4)| TANGO OPTIMO, # (B)(4)