BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1569602 · Received December 2, 2009

    Report

    Report Number
    1823260-2009-08146
    Event Type
    Malfunction
    Date Received
    December 2, 2009
    Date of Event
    November 4, 2009
    Report Date
    December 2, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER WAS SWITCHING FROM REAGENT LOT NUMBER 153686 TO REAGENT LOT NUMBER 155150 AND REPORTED OUT RESULTS FROM THE NEW REAGENT LOT FOR 20 PT SERUM SAMPLES. THE USER THEN REPEATED THE SAMPLES ON (B) (6) 2009 WITH THE OLD REAGENT LOT WITH DIFFERING RESULTS. THE USER PROVIDED RESULTS FOR SIX SAMPLES. ALL RESULTS ARE IN NG PER ML. SAMPLE 1 RESULT WITH LOT 155150 WAS 1.5, RESULT WITH LOT 153686 WAS 3.7. SAMPLE 2 RESULT WITH LOT 155150 WAS 1.5, RESULT WITH LOT 153686 WAS 3.4. SAMPLE 3 RESULT WITH LOT 155150 WAS 1.8, RESULT WITH LOT 153686 WAS 3.6. SAMPLE 4 RESULT WITH LOT 155150 WAS 1.8, RESULT WITH LOT 153686 WAS 3.7. SAMPLE 5 RESULT WITH LOT 155150 WAS 2.4, RESULT WITH LOT 153686 WAS 3.7. SAMPLE 6 RESULT WITH LOT 155150 WAS 2.6, RESULT WITH LOT 153686 WAS 3.7. THE USER DID NOT CORRECT THE RESULTS. THE USER STATED THE PTS WERE NOT ADVERSELY AFFECTED AND SAID HE HAD NOT RECEIVED ANY CALLS FROM PHYSICIANS. THE USER REFUSED A SERVICE VISIT AND STATED THE INSTRUMENT WAS FINE. A REAGENT BULLETIN, WHICH INCLUDES THE NEW LOT USED BY THE CUSTOMER, HAS BEEN ISSUED COMMUNICATING THE CKMB REAGENT HAS BEEN RESTANDARDIZED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK