BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3062711 · Received April 17, 2013

    Report

    Report Number
    1823260-2013-02326
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 14, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFOMRATION HAS BEEN PROVIDED BY THE CUSTOMER. THE PATIENT'S INITIAL HCGB RESULT WAS 208 IU/L.

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION WAS NOT PROVIDED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULT FOR ONE PATIENT ON THEIR E170 ANALYZER. THE PATIENT'S INITIAL HCGB RESULT WAS EITHER 200 IU/L OR 208 IU/L AND IT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2013, THE PATIENT'S SAMPLE WAS REPEATED ON ANOTHER ANALYZER. THE CUSTOMER INITIALLY STATED THE REPEAT RESULT WAS <0.1 IU/L. THE CUSTOMER THEN PROVIDED REPEAT RESULTS OF 0.211 IU/L AND 0.239 IU/L. THERE WERE NO ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS AND EXPIRATION DATE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165134 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 032 YR