BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 2001378 · Received February 25, 2011

    Report

    Report Number
    1823260-2011-01034
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 7, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INFORMATION PROVIDED, BOTH RESULTS WERE WITHIN THE COEFFICIENT OF VARIATION PERFORMANCE FOR THE ASSAY. NO ERRONEOUS RESULTS WERE GENERATED. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER EXPERIENCED AN INTERMITTENT ISSUE WITH QUESTIONABLE TROPONIN T AND TROPONIN T STAT GENERATION 4 (TROPONIN T STAT) RESULTS THAT WAS ONGOING SINCE (B)(6). THE USER PROVIDED DATA FOR ONE PATIENT SAMPLE. THE SAMPLE WAS INITIALLY TESTED ON COBAS E411 SERIAL NUMBER (B)(4) AT A SISTER SITE. THE INITIAL TROPONIN T RESULT WAS 0.086 NG/ML WITH A DATA FLAG AND THE INITIAL TROPONIN T STAT RESULT WAS 0.021 NG/ML. THE REPEAT TROPONIN T RESULT WAS 0.038 NG/ML WITH A DATA FLAG AND THE REPEAT TROPONIN T STAT RESULT WAS 0.023 NG/ML. THE SAMPLE WAS THEN TESTED ON THE E411 AT THIS SITE. THE TROPONIN T RESULT WAS 0.016 NG/ML AND THE TROPONIN T STAT RESULT WAS 0.023 NG/ML. A RESULT OF 0.02 NG/ML WAS REPORTED FOR THIS SAMPLE AT THE SISTER SITE. THE RESULTS FROM THIS ANALYZER WERE NOT REPORTED OUTSIDE THE LABORATORY AS THE SAMPLE WAS ONLY TESTED AS VERIFICATION FOR THEIR SISTER HOSPITAL. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TROPONIN T REAGENT LOT NUMBER WAS 15930001 AND THE TROPONIN T STAT REAGENT LOT NUMBER WAS 15989402. THE USER DECLINED A SERVICE VISIT AS SHE STATED THE SAMPLE WAS WITHIN THEIR IN-HOUSE PRECISION GUIDELINES AND SHE DID NOT BELIEVE THERE WAS AN ANALYZER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR