BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3646603 · Received February 26, 2014

    Report

    Report Number
    1823260-2014-01307
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 26, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 TESTOSTERONE RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 6.7 NG/ML AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 308 NG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT AND WAS REPORTED. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TESTOSTERONE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE LIQUID LEVEL DETECTION (LLD) VOLTAGE WAS OUT OF RANGE. HE EXAMINED QUALITY OF SPECIMEN AND FOUND NO ABNORMALITY. HE EXAMINED THE UNIT AND CHECKED OPERATION OF THE MECHANICAL AND FLUID SYSTEMS AND ALL WERE OK. HE CHECKED THE SAMPLE LLD VOLTAGE, FOUND IT WAS OUT OF RANGE AND ADJUSTED IT TO SPECIFICATIONS HE RAN PERFORMANCE TESTING ON BOTH MEASURING CELLS AND ALL RESULTS WERE WITHIN SPECIFICATIONS. HE REVIEWED CALIBRATIONS AND QC RECOVERY WHICH WAS OK. HE VERIFIED THE OPERATION OF THE SYSTEM AND CONFIRMED THE INSTRUMENT WAS OPERATING TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118559 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1