BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2943383 · Received February 5, 2013

    Report

    Report Number
    1823260-2013-00670
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 13, 2013
    Report Date
    February 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
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULTS ON THEIR E-MODULE. THE CUSTOMER PROVIDED DATA FOR 23 PATIENTS, OF WHICH 15 PATIENTS HAD DISCREPANT RESULTS. PLEASE REFER TO THE ATTACHMENT TO THE MEDWATCH FOR PATIENT DATA. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS 167584 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE. HE CHECKED THE BEAD MIXER AND THE ALIGNMENT WAS OK. HE CHECKED THE HORIZONTAL AND VERTICAL ADJUSTMENTS OF THE REAGENT PROBE AND IT WAS OK. HE TESTED THE REAGENT PROBE EXCHANGE BETWEEN MODULES AND RECEIVED A MOVEMENT ALARM. HE RECEIVED AN ALARM WHEN PIPETTING REAGENTS WITH LOW VOLUMES. HE PERFORMED CLEANING AND A VISUAL INSPECTION OF THE FLAT CABLE MECHANISM. HE FOUND A POSSIBLE FAILURE POINT ON THE TRACK. HE ISOLATED THE TRAIL. AFTERWARDS, HE PERFORMED QUALITY CONTROL WITH OK RESULTS. HE WENT BACK ON SITE LATER AND REPLACED THE FLAT CABLE SUCCESSFULLY. HE THEN PERFORMED A PRECISION TEST AND THE RESULTS WERE OK. THE MODULE HAS BEEN IN ROUTINE SERVICE SINCE (B)(4) 2013 WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48329 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 033 YR