BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3893548 · Received June 25, 2014

    Report

    Report Number
    1823260-2014-04649
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE VITAMIN B12 REAGENT LOT NUMBER WAS 174159. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE VITAMIN B12 RESULTS FOR FOUR PATIENT SAMPLES THAT HAD BEEN TESTED IN ALIQUOT CUPS PRODUCED BY THE MODULAR PREANALYTIC ANALYZER (MPA). OF THE DATA PROVIDED, ONLY THE RESULTS FOR ONE PATIENT SAMPLE WERE A REPORTABLE MALFUNCTION. THE INITIAL RESULT WAS 30.78 PMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED AND THE RESULT WAS 559 PMOL/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE VITAMIN B12 REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370403 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1