BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 602 MODULE

    MDR report key: 7128237 · Received December 19, 2017

    Report

    Report Number
    1823260-2017-02997
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    December 1, 2017
    Report Date
    January 29, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. TYPICAL CAUSES FOR THIS TYPE OF EVENT INCLUDE ISSUES WITH SAMPLE QUALITY OR INSUFFICIENT ANALYZER MAINTENANCE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE LOW ELECSYS TESTOSTERONE II ASSAY RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 6.03 NG/DL AND WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2017, THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 419.6 NG/DL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 232994. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE PROVIDED CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE WAS NOT SUSPECTED. ALARMS INDICATING ABNORMAL SAMPLE ASPIRATION WERE NOTED. THEREFORE, A SAMPLE CLOT OR INADEQUATE SAMPLE VOLUME WERE POSSIBLE ROOT CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908358 COBAS 8000 E 602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1