BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1713886 · Received June 8, 2010

    Report

    Report Number
    1823260-2010-03407
    Event Type
    Malfunction
    Date Received
    June 8, 2010
    Date of Event
    May 21, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR IF INITIAL REPORTER SENT REPORT TO FDA.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION PROVIDED, THE HUMIDITY IN THE LABORATORY IS SLIGHTLY BELOW SPECIFICATION AND THE INSTRUMENT WAS DUE FOR MAINTENANCE. THESE ISSUES MAY HAVE CONTRIBUTED TO THE EVENT. NO ADVERSE EVENTS IN RELATION TO THE ISSUE WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONVERTED TO TROPONIN T HIGH SENSITIVE (HS) ASSAY AND TESTED SAMPLES FOR ONE WEEK ON BOTH THIS ANALYZER AND A DIFFERENT E601 MODULE AND OBTAINED DIFFERING RESULTS. RESULTS FOR 10 PATIENT SAMPLES WERE PROVIDED, SIX WERE DISCREPANT. THE E601 ANALYZERS HAVE DIFFERENT UNITS OF MEASURE FOR THE TROPONIN T HS ASSAY. PATIENT 1, INITIAL TROPONIN T HS RESULT 137.9 NG/L (ACCOMPANIED BY H DATA FLAG), REPEATED TWICE GAVE 0.10 UG/L (DIFFERENT E601) AND 138.4 NG/L (ORIGINAL ANALYZER, ACCOMPANIED BY H DATA FLAG). PATIENT 2, INITIAL TROPONIN T HS RESULT 17.75 NG/L, REPEATED TWICE GAVE 3.70 UG/L (DIFFERENT E601) AND 41.04 NG/L (ORIGINAL ANALYZER). PATIENT 3, INITIAL TROPONIN T HS RESULT 1860 NG/L (ACCOMPANIED BY H DATA FLAG), REPEATED TWICE GAVE 1.57 UG/L (DIFFERENT E601) AND 6.90 NG/L (ORIGINAL ANALYZER). PATIENT 4, INITIAL TROPONIN T HS RESULT 84.46 NG/L (ACCOMPANIED BY H DATA FLAG), REPEATED TWICE GAVE 0.06 UG/L (DIFFERENT E601) AND 82.99 NG/L (ORIGINAL ANALYZER, ACCOMPANIED BY H DATA FLAG). PATIENT 5, INITIAL TROPONIN T HS RESULT 56.03 NG/L (ACCOMPANIED BY H DATA FLAG), REPEATED TWICE GAVE 0.04 UG/L (DIFFERENT E601) AND 55.72 NG/L (ORIGINAL ANALYZER, ACCOMPANIED BY H DATA FLAG). PATIENT 6, INITIAL TROPONIN T HS RESULT 291.4 NG/L (ACCOMPANIED BY H DATA FLAG), REPEATED ONCE GAVE 0.24 UG/L (DIFFERENT E601). IT IS UNKNOWN WHICH TROPONIN T HS RESULTS WERE REPORTED. NO ADVERSE EVENTS WERE REPORTED. TROPONIN T HS REAGENT LOT IS 156593. INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DISPLAYS ERROR 5 MESSAGE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1