BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2842536 · Received November 21, 2012

    Report

    Report Number
    1823260-2012-05929
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 21, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ESTRADIOL GENERATION 2 (ESTRADIOL) RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 348.6 PG/ML AND WAS REPORTED OUTSIDE THE LABORATORY AS 349.0 PG/ML. THE PATIENT'S PHYSICIAN CALLED TO QUESTION THE RESULT AND REQUESTED REPEAT TESTING OF THE SAMPLE. ON (B)(6) 2012, THE SAMPLE WAS REPEATED WITH RESULT OF 27.99 PG/ML, 35.58 PG/ML AND 29.47 PG/ML. THE REPEAT RESULT OF 29.47 PG/ML WHICH WAS ROUNDED TO 29.5 PG/ML WAS BELIEVED TO BE THE CORRECT RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE ESTRADIOL REAGENT LOT NUMBER WAS 16871101 WITH AN EXPIRATION DATE OF 05/31/2013. THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. A REAGENT ISSUE WAS NOT SUSPECTED AS CALIBRATION AND QC DATA WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 044 YR