BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3673183 · Received March 11, 2014

    Report

    Report Number
    1823260-2014-01717
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    February 11, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE CALIBRATION RESULTS WERE WITHIN RANGE. THE QUALITY CONTROL AFTER THE EVENT WAS OUT OF RANGE. AFTER A LIQUID FLOW CLEANING, THE QUALITY CONTROL WAS BACK IN RANGE. THERE WERE INSTRUMENT ALARMS ON THE DAY OF THE EVENT. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE DEHYDROEPIANDROSTERONE SULFATE (DHEA) RESULTS ON THEIR E-MODULE. THE CUSTOMER INDICATED THERE WERE TWO PATIENTS INVOLVED IN THIS EVENT. THE CUSTOMER ONLY PROVIDED DATA FOR ONE PATIENT WITH A DISCREPANT RESULT. INFORMATION ABOUT THE SECOND PATIENT WAS REQUESTED BUT NOT PROVIDED. THE CUSTOMER STATED THAT IN THE MORNING OF (B)(6) 2014, THE QUALITY CONTROL RESULTS WERE IN THE ACCEPTABLE RANGE. IN THE AFTERNOON, THE CUSTOMER PERFORMED QUALITY CONTROL AND ALL THE ASSAYS HAD RESULTS OUT OF THE ACCEPTABLE RANGE. ON (B)(6) 2014, THE CUSTOMER PERFORMED A LIQUID FLOW CLEANING. THE CUSTOMER THEN PERFORMED QUALITY CONTROL AND ALL THE RESULTS WERE IN THE ACCEPTABLE RANGE. BETWEEN WHEN QUALITY CONTROL WAS RUN IN THE MORNING AND THE FAILED QUALITY CONTROL IN THE AFTERNOON OF (B)(6) 2014, THE CUSTOMER MEASURED 32 SAMPLES. THE CUSTOMER REPEATED SOME OF THE 32 SAMPLES TESTED BETWEEN THE QUALITY CONTROL RUNS, AND THERE WAS ONLY ONE SAMPLE WITH A DISCREPANT DHEA RESULT. THE PATIENT'S INITIAL DHEA RESULT WAS 28.6 UG/DL AND IT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2014, THE REPEAT RESULT WAS 17.03 UG/DL. THERE WERE NO ADVERSE EVENTS. THE DHEA REAGENT LOT NUMBER WAS 172935. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144666 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR LIPITOR| GLIFAGE| PURAN T4| ULTRASSET| LEXAPRO| AAS