BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 2911702 · Received January 11, 2013

    Report

    Report Number
    1823260-2013-00259
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 20, 2012
    Report Date
    April 10, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BACKUP DATA SUPPLIED BY THE CUSTOMER WAS INVESTIGATED. UNFORTUNATELY, THERE WAS NO DATA FROM THE TIME OF THE EVENT. THE INFORMATION PROVIDED DID NOT SHOW ANY REASON THAT THE HARDWARE OR SOFTWARE DID NOT WORK AS REQUIRED.

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. SEVERAL ANALYZER ALARMS WERE NOTED DURING THE TIME OF THE EVENT. A REAGENT PROBLEM CAN MOST PROBABLY BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE FREE THYROXINE (FT4), THYROTROPIN (TSH), AND INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS- SUBUNIT (HGCB) RESULTS ON THEIR E602 ANALYZER. THE CUSTOMER PROVIDED DATA FOR (B)(6) PATIENTS, OF WHICH (B)(6) HAD DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. A DOCTOR QUESTIONED THE RESULTS, AND THE SAMPLES WERE REPEATED. REPEAT TESTING WAS PERFORMED ON (B)(6) 2012. THE UNITS OF MEASURE WERE NOT PROVIDED. PLEASE REFER TO THE ATTACHMENT TO THE MEDWATCH FOR THE PATIENT RESULTS. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND ISSUED AS CORRECTED REPORTS. THERE WERE NO ADVERSE EVENTS. THE FT4 REAGENT LOT NUMBER WAS 16944000 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE TSH REAGENT LOT NUMBER WAS 16997200 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE HCGB REAGENT LOT NUMBER WAS 16956300 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER PERFORMED TWO WEEKLY MAINTENANCES AND AN ASSAY PERFORMANCE CHECK. THE ANALYZER SEEMED TO BE WORKING OK AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17396 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1