BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3131924 · Received May 29, 2013

    Report

    Report Number
    1823260-2013-03206
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    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 OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE (B)(6) RESULTS ON THEIR E-MODULE. THE CUSTOMER PROVIDED DATA FOR 23 PATIENTS, OF WHICH 14 HAD DISCREPANT (B)(6) RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE ISSUED AS CORRECTED REPORTS. IT WAS UNKNOWN IF THERE WERE ANY ADVERSE EVENTS. THE (B)(6) REAGENT LOT NUMBER WAS 170493 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER PERFORMED A REAGENT PROBE CLEANING. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE. HE PERFORMED A DECONTAMINATION OF THE SYSTEM BECAUSE HE FOUND DIRTY, WHITE PARTICLES. THE FSR STATED THEY WERE PROBABLY FROM THE WATER TANK AND "TABULATION". THE INSTRUMENT WAS WORKING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237456 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1