BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3883747 · Received June 19, 2014

    Report

    Report Number
    1823260-2014-04465
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    July 23, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DATA WERE REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN RANGE AND THERE WAS NO INDICATION OF A GENERAL REAGENT OR SYSTEM ISSUE. IT WAS NOTED THE CUSTOMER WAS NOT USING THE RECOMMENDED RACK ADAPTORS. THE PERFORMANCE TESTING DATA WERE WITHIN SPECIFICATIONS. THE MEASURING CELLS WERE EXCHANGED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE HUMAN CHORIONIC GONADOTROPIN, STAT (HCG) RESULT FOR ONE PATIENT ON THEIR E-MODULE. THE SPECIFIC DATE OF THIS EVENT WAS REQUESTED BUT NOT PROVIDED. THE UNITS OF MEASURE WERE REQUESTED BUT NOT PROVIDED. THE PATIENT'S INITIAL HCG RESULT WAS 4. THE REPEAT RESULT WAS 40. INFORMATION ON WHETHER THE DISCREPANT RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. INFORMATION ON WHETHER THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE HCG REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361729 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1