BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANGO OPTIMO

    MDR report key: 2664379 · Received July 23, 2012

    Report

    Report Number
    9610824-2012-00114
    Event Type
    Malfunction
    Date Received
    July 23, 2012
    Date of Event
    June 28, 2012
    Report Date
    July 23, 2012
    Manufacturer
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Product Code
    KSZ
    PMA / PMN Number
    BK080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REPORTED THAT A SAMPLE YIELDED IN A SOFTBANK SCREEN A 4+ RESULT IN THE A SPOT AND THE CORD TYPE WAS INTERPRETED AS "POS POS" WHILE TESTING ON THE TANGO YIELDED CLEARLY AN O POS RESULT. THE CUSTOMER CAUGHT THE ANOMALY BEFORE THERE WAS AN ADVERSE RESULT. A REVIEW OF THE TANGO'S RESULT SHEETS DELIVERED CLEARLY SHOW A NEGATIVE REACTION OF THE SAMPLE WITH ANTI-A WHEREAS THE RESULT PRINTOUT FROM SOFTBANK SHOWS A 4+. SINCE THERE IS NO SAMPLE ID VISIBLE ON THE SOFTBANK PRINTOUT (WINDOW ABOVE WINDOW), THERE IS NO EVIDENCE THAT THE DISCREPANT RESULTS ARE ASSIGNED TO THE SAME INDIVIDUAL. BIO-RAD US TECH SUPPORT WAS NOTIFIED ABOUT THE PROPOSAL OF A WORKAROUND SOLUTION GIVEN BY SCC (VENDOR OF SOFTBANK) UNTIL A SUSTAINED RESOLUTION IS AVAILABLE. TAKEN TOGETHER NO FALSE RESULTS HAVE BEEN OBTAINED WITH TANGO OPTIMO S/N (B)(4). PROVIDED THAT DISCREPANT RESULTS HAVE REALLY BEEN ASSIGNED TO AN IDENTICAL PATIENT (NO EVIDENCE) THE ISSUE AROSE DUE TO MIXUP OF THE ORDER OF RESULTS FROM A PARTIALLY REORDERED SAMPLE DURING TRANSFER TO THE HOST SYSTEM VIA SOFTBANK. PRELIMINARY INFORMATION CONCLUDE THAT REPROGRAMMING OF SOFTBANK SHALL PREVENT THE PROBLEM AFTER IMPLEMENTATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1