BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 3182249 · Received June 21, 2013

    Report

    Report Number
    1823260-2013-03759
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 16, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATIONS COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. A REAGENT ISSUE IS UNLIKELY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR INTACT HUMAN CHORIONIC GONADOTROPIN PLUS THE SS-SUBUNIT (HCG+SS). THE SAMPLE INITIALLY RESULTED AS 11.73 MIU/ML AND THIS RESULT WAS DISCUSSED WITH THE PHYSICIAN. THE RESULT DID NOT MATCH WITH THE PATIENT'S CLINICAL PICTURE, SO THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 0.248 MIU/ML AND THIS VALUE WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED A SECOND TIME, RESULTING AS 0.721 MIU/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE HCG+SS REAGENT LOT NUMBER WAS 16956305 WITH AN EXPIRATION DATE OF 01/31/2014. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE S/R PROBE NEEDED ADJUSTMENT AT THE SAMPLE POSITION. HE PERFORMED S/R PROBE ALIGNMENTS, CHECKED THE WATER FILTER, CHECKED THE MIXING SPEED, AND VERIFIED PROPER SIPPER ALIGNMENTS. HE RAN PERFORMANCE TESTING AND ALL RESULTS MET SPECIFICATIONS. THE CUSTOMER RAN CALIBRATIONS AND QUALITY CONTROLS WITH ALL RESULTS MEETING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281852 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR