BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 2152823 · Received June 27, 2011

    Report

    Report Number
    9610824-2011-00086
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BIO-RED MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORRECT FUNCTION OF THE AFFECTED REAGENTS WERE PROVED BY TESTING THE RETENTION SAMPLES OF QUALITY CONTROL LABORATORY ON TANGO. ALL (B)(6) AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY (B)(6) REACTIONS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE AFFECTED NEGATIVELY THE QUALITY OF THE COMPLAINED LOTS.

    Description of Event or Problem · 1

    THE CUSTOMER RAN SAMPLE #1 ((B)(6)) ON THE TANGO. THE SAMPLE IS FROM PATIENT WITH ANTI-D AND A HISTORY OF ANTI-JKA. PROTEIN LEVEL IS 5 G/DL. IN THE SAME BATCH, SAMPLE #2 ((B)(6)) WAS RUN, A KNOWN A POS WITH NO UNEXPECTED ANTIBODY. SAMPLE #2 WAS ANTIBODY SCREEN (B)(6) ON THE TANGO. CELL 1 AND 2 WERE 3+. SAMPLE #2 WAS RUN SEPARATELY AGAIN ON ORTHO GEL AND THE SCREEN WAS STILL (B)(6), SO THE CUSTOMER BELIEVES THAT NOT ONLY WAS THERE CARRY-OVER, BUT SAMPLE #2 ITSELF WAS CONTAMINATED. A REDRAW ON SAMPLE #2 DID HAVE A NEGATIVE ANTIBODY SCREEN. IN THE SAME BATCH, SAMPLE #3 ((B)(4)) WAS RUN ALSO. THIS SAMPLE WAS AN O POS BUT THE TANGO READ ALL THE FRONT TYPE AS 3+ INCLUDING THE NEG CONTROL, THE SCREEN WAS ALSO POSITIVE 3+ BOTH CELLS, WHEN IT SHOULD HAVE BEEN NEGATIVE. THEY RAN SAMPLE #3 SEPARATELY ON JUNE 9 ON THE TANGO FOR A PANEL AND ONLY CELL #4 WAS (B)(6), SHOWING A LITTLE CONTAMINATION LEFT IN THE SAMPLE ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANGO OPTIMO AUTOMATED BLOOD BANK ANALYZER SYSTEM KSZ BIO-RED MEDICAL DIAGNOSTICS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 AHG ANTI-IGG SOLIDSCREEN II: LOT 7035091-04| EXP. 02/25/2012| BIOTESTCELL 1&2: LOT 8119011