BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK

    MDR report key: 1181070 · Received September 29, 2008

    Report

    Report Number
    1823260-2008-07245
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT TSH RESULTS FOR TWO PATIENTS ON TWO SEPARATE DAYS. INITIAL RESULT 0.040 UIU/ML, REPEATED TWICE GAVE 3.23 AND 3.22 UIU/ML. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DUPLICATE THE PROBLEM OR DETERMINE THE CAUSE. HE NOTED MINOR ADJUSTMENTS WERE MADE TO THE S/R PROBE AND HE ORDERED A NEW SAMPLE DISK TO REPLACE A WORN DISK. PERFORMANCE TESTS WERE PERFORMED.

    Description of Event or Problem · 2

    USER EXPERIENCED DISCREPANT TSH RESULTS FOR TWO PATIENTS ON TWO SEPARATE DAYS. PATIENT TESTED IN 2008, INITIAL RESULT 0.035 MIU/ML, REPEAT GAVE 1.61 MIU/ML. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DUPLICATE THE PROBLEM OR DETERMINE THE CAUSE. HE NOTED MINOR ADJUSTMENTS WERE MADE TO THE S/R PROBE AND HE ORDERED A NEW SAMPLE DISK TO REPLACE A WORN DISK. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 DISK IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS CORP. E411 DISK

    Patients

    Seq Age Sex Outcome Treatment
    1
    2 UNK