BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3101835 · Received May 9, 2013

    Report

    Report Number
    1823260-2013-02833
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 15, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S C-PEPTIDE RESULT OF 0.5 NG/ML, WHICH IS BELOW THE EXPECTED VALUE, CONFIRMS THE ELECSYS INSULIN RESULTS BELOW THE EXPECTED VALUES. THE PATIENT'S HIGH RESULTS FOR GLUCOSE AND HBA1C SUPPORT THE CLINICAL PICTURE OF RELATIVELY REDUCED INSULIN SECRETION. THE COMPETITOR'S RESULTS ARE LIKELY DUE TO CROSS-REACTIVITY WITH INSULIN ANALOGS USED IN TYPE 2 DIABETES THERAPY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT ALLEGED THEY RECEIVED QUESTIONABLE INSULIN RESULTS ON THEIR E170 ANALYZER. DURING AN ALMOST NINE MONTH PERIOD, THE CUSTOMER ALLEGED THEY HAD 4-5 EVENTS. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT WITH DISCREPANT RESULTS. THE PATIENT'S RESULT FROM THE E170 ANALYZER WAS 1.7 UU/ML. THE PATIENT'S SAMPLE WAS TESTED ON THE RIA METHOD AND THE RESULT WAS 49.7 UU/ML. THE PATIENT'S SAMPLE WAS TESTED ON A SIEMENS CENTAUR ANALYZER AND THE RESULT WAS 55.9 UU/ML. ALL THREE RESULTS WERE REPORTED OUTSIDE THE LABORATORY, WITH THE 49.7 RESULTS BEING REPORTED AS THE FINAL REPORT. THERE WERE NO ADVERSE EVENTS. THE INSULIN REAGENT LOT AND EXPIRATION DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203241 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 030 YR