BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 2925980 · Received January 23, 2013

    Report

    Report Number
    9610824-2013-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 23, 2013
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 HAD REPORTED FALSE POSITIVE REACTIONS PRESUMABLY CAUSED BY CARRY OVER. ONE PATIENT SAMPLE YIELDED A 1+ REACTION IN CELL #1 AND A NEGATIVE REACTION IN CELL #2 WHEN PIPETTED ADJACENTLY TO THE KNOWN ANTI-D POS. SAMPLE OF PATIENT ONE AND RESULTING NEGATIVE ON BOTH CELLS WHEN TESTED INDEPENDENTLY FROM OTHER SAMPLES ON THE SAME INSTRUMENT. THE CORRECT FUNCTION OF THE CONCOMITANTLY USED ALLEGEDLY DEFECTIVE REAGENTS WERE PROVED BY TESTING THE RETAINED SAMPLES OF OUR QUALITY CONTROL LABORATORY ON TANGO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS. A REVIEW OF THE BATCH RECORD DOCUMENTATION SHOWED NO IRREGULARITIES WHICH MIGHT HAVE NEGATIVELY AFFECTED THE QUALITY OF THE COMPLAINED LOTS. THE TECHNICAL FIELD SERVICE CHECKED THE AFFECTED TANGO OPTIMO AND FOUND THE RESULT CAMERA SETTINGS TO BE IN THE SPECIFIED RANGE WITH NO INDICATION TO PERFORMANCE ISSUES. THE CARRYOVER EVENT COULD BE REPRODUCED ON BMD'S TANGO OPTIMO USING THE US THREE CELL SCREEN ASSAY (ABSD3). THE KNOWN ANTI-D POS. SAMPLE (PATIENT SAMPLE 1) YIELDED 4-FOLD POSITIVE REACTIONS WITH CELL P1 AND P2, P3 BEING NEGATIVE. THE ONLY POSITIVE (+/- ON VISUAL ASSESSMENT) REACTION ON THREE ADJACENTLY PIPETTED KNOWN NEGATIVE DONOR SAMPLES OCCURRED ON CELL P1 OF THE FIRST FOLLOWING SAMPLE. THERE WAS NOT ENOUGH MATERIAL TO PERFORM AN ENDPOINT TITRATION. OUR TESTINGS STRONGLY SUGGEST THAT A CARRY-OVER EVENT HAS HAPPENED AT THE CUSTOMER'S SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32514 TANGO OPTIMO AUTOMATED BLOOD BANK ANALYSER SYSTEM KSZ BIO-RAD MEDICAL DIAGNOSTICS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 BIOTESTCELL 1,2, LOT 8247021, EXP. 01/08/13| MLB2, LOT 8220091, EXP. 05/06/2014| ANTI-HUMAN-GLOBULIN, LOT 8221110-02, EXP. 11/14/13| BIOTESTCELL-I11, LOT 8247011, EXP. 01/08/2013