BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1993004 · Received February 16, 2011

    Report

    Report Number
    1823260-2011-00861
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 24, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. DURING THE INVESTIGATION, A DIFFERENCE IN SPECIFIC TROPONIN I RESULTS BETWEEN EDTA AND LITHIUM HEPARIN PLASMA COULD NOT BE CONFIRMED. NO KNOWN TREATMENT WAS PROVIDED AND NO KNOWN DEATH OR SERIOUS INJURY EVENT OCCURRED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE TROPONIN I STAT RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS BEGINNING ON (B)(6) 2011. THE USER TESTED EDTA AND LITHIUM HEPARIN PLASMA SAMPLES FROM THE SAME VENIPUNCTURES ON THE ELECSYS 2010 AND THE COBAS E601 ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR ONE PATIENT SAMPLE TESTED ON (B)(6) 2011 WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. ALL RESULTS ARE IN NG/ML. THE EDTA PLASMA SAMPLE WAS RUN TWICE ON THE ELECSYS 2010 WITH RESULTS OF >25.0 WITH A DATA FLAG EACH TIME. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE RESULT FROM THE ELECSYS 2010 ON THE LITHIUM HEPARIN SAMPLE WAS 11.76 WITH A DATA FLAG. A CORRECTED REPORT WAS SENT WITH THIS RESULT. THE LITHIUM HEPARIN SAMPLE TESTED ON THE COBAS E601 HAD A RESULT OF 10.48. THE LITHIUM HEPARIN SAMPLE FROM ONE OF THE LAST TWO VENIPUNCTURES FROM THIS PATIENT WAS SENT TO ANOTHER LABORATORY FOR TESTING AND THE RESULT WAS 18.56. THE USER DID NOT HAVE INFORMATION AVAILABLE TO DETERMINE WHICH SAMPLE WAS SENT. THE USER CONSIDERED THE RESULTS FROM THE LITHIUM HEPARIN SAMPLES TO BE CORRECT. THE USER DID NOT KNOW IF THE PATIENTS WERE ADVERSELY AFFECTED. THE TROPONIN I STAT REAGENT LOT NUMBER WAS 15779101. THE USER DECLINED A SERVICE VISIT AND STATED THE ISSUE APPEARED TO BE SAMPLE RELATED AND NOT AN ANALYZER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR