BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 2220647 · Received June 21, 2011

    Report

    Report Number
    9610824-2011-00084
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THEY EXPERIENCED CARRY-OVER. FIRST SAMPLE POSITIVE FOR ANTI-D AND ANTI-C WAS 4+ IN CELL 1 AND 2 OF THE BIOTESTCELL 3. SAMPLE RUN IMMEDIATELY AFTERWARDS IN THE BATCH WAS 3+ IN CELL 1 AND 2+ IN CELL 2. THE SECOND SAMPLE'S PANEL WAS NEGATIVE AND WHEN RUN INDEPENDENTLY ON THE TANGO FOR ANTI-BODY SCREEN IS CORRECTLY NEGATIVE. ANTIBODY SCREENING WAS REPRODUCED USING THE PROVIDED SAMPLE ON TANGO OPTIMO S/N (B)(4). THE ANTIBODY CONTAINING SAMPLE WAS CHOSEN TO BE THE FIRST ONE IN ORDER, FOLLOWED BY FOUR KNOWN NEGATIVE DONOR SAMPLES. IN THIS APPROACH ALL STEPS OF THE PROCESS WERE CONDUCTED AUTOMATICALLY BY TANGO OPTIMO W/O ANY MANUAL INTERVENTION. THE ORIGINAL, ANTIBODY-CONTAINING SAMPLE RESULTED IN A STRONG POSITIVE (4+) REACTION REGARDING P1 AND P2 CELLS. P3 REACTED CLEARLY NEGATIVE. THE FIRST FOLLOWING KNOWN NEGATIVE SAMPLE RESULTED IN A POSITIVE (2+) REACTION ONLY WITH P1 CELLS. ALL OTHER KNOWN NEGATIVE SAMPLES REACTED NEGATIVE WITH ALL OF THE TESTCELLS. THE CORRECT FUNCTION OF THE AFFECTED REAGENTS WERE PROVED BY TESTING THE RETENTION SAMPLES OF QC LAB ON TANGO. ALL POSITIVE AND NEGATIVE REACTIONS WERE CORRECT. WE DID NOT OBSERVE ANY FALSE POSITIVE REACTIONS OF THE AFFECTED REAGENTS THEMSELVES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 SOLIDSCREEN II STRIP: LOT 8110070| AHG ANTI-IGG SOLIDSCREEN II:| LOT 8102140-04, EXP 7/6/2012| BIOTESTCELL 3: LOT 8115021, MLB2, LOT 7025121