BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 2220629 · Received July 8, 2011

    Report

    Report Number
    9610824-2011-00090
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEY RAN A SAMPLE (#1) IMMEDIATELY FOLLOWED BY SAMPLE (#2) IN THE SAME BATCH FOR BIOTESTCELL 3. SHE STATES THAT SAMPLE #1 WAS 4+ IN CELL 1 AND CELL 2 AND HAS AN ANTI-D. SAMPLE #2 WAS 3+ IN CELL 1 ONLY. REPEAT TESTING ON SAMPLE #2 AND PANEL IS NEGATIVE. THE CUSTOMER BELIEVES THAT SAMPLE #1 CAUSED CARRY-OVER INTO SAMPLE #2. CUSTOMER REFUSED TO PROVIDE SAMPLES IN QUESTION OR ACCESS TO THE LAB FOR SPECIFIC SVC INTERVENTION, SO WE REVIEWED THE LAST FIELD SVC REPORT. ACCORDING TO THIS FIELD SVC REPORT FROM (B)(6) 2011, THERE IS NO INDICATION FOR ANY INSTRUMENT MALFUNCTION. QC RUNS AS REQUIRED BY THE LOCATION PASSED SUCCESSFULLY. SINCE THE CUSTOMER IS NEITHER WILLING TO PROVIDE ANY RESULT IMAGES, DATA OR SAMPLES NOR TO ALLOW ANY FURTHER SVC ACTIVITIES, WE ARE NOT IN THE POSITION TO PERFORM DETAILED ROOT CAUSE ANALYSIS OF THE REPORTED ISSUE. BASED ON THE LIMITED INFO AVAILABLE IT SEEMS TO BE VERY LIKELY THAT THE POSITIVE REACTION FROM SAMPLE #2 WITH WAS INDUCED BY A CARRYOVER EVENT FROM SAMPLE #1 (ANTI-D POS).

    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 LOT 8102140-02, EXP 07/06/2012| AHG ANTI-IGG SOLIDSCREEN II:| BIOTESTCELL 3: LOT 8119021, MLB2, LOT 8046070| SOLIDSCREEN II STRIP: LOT 8106110