BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1834182 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05441
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 31, 2010
    Report Date
    December 3, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SAMPLES WERE PROVIDED FOR INVESTIGATION. THE CUSTOMER'S RESULTS WERE VERIFIED. THE SAMPLES WERE FURTHER TESTED ON ANOTHER COMPETITOR ASSAY SIEMENS CENTAUR, AND THE VALUES OBTAINED WERE HIGHER THAN 100 U/L. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. NO DETAILED PATIENT DATA WAS PROVIDED IN THIS CASE. OTHER TESTING, SUCH AS HBSAG AS WELL AS ANTI- HBC WERE UNKNOWN. THE CLINICAL STATUS OF THE PATIENTS COULD NOT BE CONCLUDED. DESPITE THE DIFFERENT VALUES OBTAINED FROM THE TWO ASSAYS, THERE WAS NO ESSENTIAL DIFFERENCE IN THE RESULT INTERPRETATION. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE ANTI-HBS (ANTIBODY TO HEPATITIS B SURFACE ANTIGEN) RESULTS FOR TWO PATIENT SAMPLES FROM THE COBAS E601 ANALYZER. OF THE PROVIDED DATA, THE RESULTS FOR ONE SAMPLE WERE DISCREPANT. THE INITIAL RESULT WAS > 1000 U/L AND REPEAT RESULT WAS 1112 U/L WITH A 1:10 DILUTION. THE SAMPLE WAS TESTED ON THE AXSYM ANALYZER AND THE RESULT WAS 53 U/L. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE DISCREPANCIES. THE LOT NUMBER OF THE ANTI-HBS REAGENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE AIMING BEAM FIRED STRAIGHT OUT OF THE FIBER AT 33,058 JOULES. THE DEVICE WAS NOT RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1