BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1891390 · Received November 4, 2010

    Report

    Report Number
    1823260-2010-06590
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 4, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE LOW TROPONIN T (TNT) RESULT ON THE ELECSYS 2010 RACK ANALYZER FOR ONE PATIENT SAMPLE. THE INITIAL TNT RESULT RUN FROM AN ALIQUOT OF THE PRIMARY SAMPLE TUBE WAS < 0.010 UG/L. THIS RESULT WAS ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED TWICE. THE FIRST REPEAT RUN FROM THE SAME ALIQUOT WAS 0.174 UG/L. THE SECOND REPEAT RUN FROM A SAMPLE CUP WAS 0.173 UG/L. THE CUSTOMERS' LABORATORY PROTOCOL IS TO REPEAT ALL TNT RESULTS FROM PATIENTS WITH NO RECENT TNT HISTORY OR TNT RESULTS THAT DO NOT MATCH PREVIOUS TNT RESULTS. THE INITIAL TNT RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THE PATIENT WAS NOT AFFECTED. THE REAGENT LOT NUMBER FOR TNT WAS 15887701. INVESTIGATION OF THE DATA PROVIDED CONCLUDED INSUFFICIENT SAMPLE CLOTTING TIME AND OR FOAM ON THE SAMPLE AS POSSIBLE CAUSES FOR THE LOW TROPONIN T RESULT. THE CUSTOMER USES A < 19 MINUTE CLOTTING TIME, AND SHOULD USE 30 MINUTE CLOTTING TIME. THE PATIENT WAS NOT AFFECTED BY THE EVENT.

    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