BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2961365 · Received February 14, 2013

    Report

    Report Number
    1823260-2013-00876
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    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.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION WAS NOT PROVIDED FOR FURTHER INVESTIGATION. MOST LIKELY AN ISSUE WITH LLD OCCURRED AS LABORATORY HUMIDITY WAS OUT OF SPECIFICATIONS. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR INTACT HUMAN CHORIONIC GONADOTROPIN PLUS THE SS-SUBUNIT (HCG+SS). THE SAMPLE INITIALLY RESULTED AS <0.100 MIU/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE DOCTOR CALLED QUESTIONING THIS RESULT, SO THE SAMPLE WAS REPEATED, RESULTING AS ">6000" MIU/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE HCG+SS REAGENT LOT NUMBER IS 16758402 WITH AN EXPIRATION DATE OF 07/31/2013. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE ISSUE WAS CAUSED BY THE LIQUID LEVEL DETECTION AND LOW HUMIDITY IN THE LABORATORY. HE EXAMINED THE UNIT AND CHECKED SAMPLE LLD, WHICH WAS OK. HE CHECKED ALIGNMENTS AND THESE WERE OK. HE REVIEWED CALIBRATION AND QUALITY CONTROLS, THESE WERE OK. HE PERFORMED PERFORMANCE TESTING WHICH WAS OK. THE INSTRUMENT WAS RUNNING WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65475 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1