BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3170711 · Received June 14, 2013

    Report

    Report Number
    1823260-2013-03606
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE TROPONIN T RESULT FOR ONE PATIENT SAMPLE. ALL RESULTS ARE IN NG/ML. THE INITIAL RESULT WAS 0.091 AND WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT HAD A SECOND SAMPLE DRAWN 4-6 HOURS LATER ON 06/04/2013. THE RESULT FOR THAT SAMPLE WAS 0.010 WITH A DATA FLAG WHICH TRIGGERED A DELTA CHECK. THE CUSTOMER REPEATED THE FIRST SAMPLE ON THE SAME ANALYZER WITH A RESULT OF <0.010 WITH A DATA FLAG. THE SAMPLE WAS ALSO REPEATED ON ANOTHER COBAS E601 ANALYZER WITH A RESULT OF <0.010 WITH A DATA FLAG. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TROPONIN T REAGENT LOT NUMBER WAS 17291301 WITH AN EXPIRATION DATE OF 06/30/2014. THE FIELD SERVICE REPRESENTATIVE FOUND THERE WAS A DAMAGED SAMPLE SEAL PIECE AND REPLACED IT. HE RAN PERFORMANCE TESTING WHICH WAS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271061 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1