BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 602 MODULE

    MDR report key: 7177882 · Received January 10, 2018

    Report

    Report Number
    1823260-2018-00105
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    December 14, 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

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. POSSIBLE ROOT CAUSES INCLUDE ISSUES WITH THE INSTRUMENT OR THE PRE-ANALYTICS. OTHER TYPICAL CAUSES FOR THIS TYPE OF EVENT INCLUDE ISSUES WITH SAMPLE QUALITY OR INSUFFICIENT ANALYZER MAINTENANCE. BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE WAS NOT EVIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS TESTOSTERONE II ASSAY RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 24.64 NG/DL AND THE REPEAT RESULT ON (B)(6) 2017 WAS 1290 NG/DL. INFORMATION CONCERNING WHICH RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WAS REQUESTED BUT WAS NOT PROVIDED. 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 CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE WAS NOT SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22934 COBAS 8000 E 602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR