BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 3111362 · Received May 14, 2013

    Report

    Report Number
    1823260-2013-02915
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    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

    THIS EVENT OCCURRED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE CALIBRATION AND QUALITY CONTROL RESULTS PRIOR TO THE EVENT WERE ACCEPTABLE. THE PERFORMANCE TESTING DATA WAS WITHIN SPECIFICATION. IT WAS NOTED THERE WERE SOME SAMPLE ASPIRATION ALARMS IN THE ALARM TRACE FROM THE TIME OF THE EVENT. IT WAS NOTED THERE WERE MESSAGES RELATING TO INSUFFICIENT PROCELL, CLEANCELL, AND PRECLEAN AROUND THE TIME OF THE ERRONEOUS RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULTS ON THEIR E602 ANALYZER. THE CUSTOMER STATED THERE WERE 62 PATIENT SAMPLES THAT WERE QUESTIONED AND REPEATED. THE CUSTOMER PROVIDED DATA FOR 42 PATIENTS, OF WHICH 37 HAD DISCREPANT RESULTS. THE OPERATORS NOTICED SOME LOW POSITIVE RESULTS AND MASKED THE HCGB TEST ON THE ANALYZER. PATIENT ONE HAD AN INITIAL HCGB RESULT OF 65.7 MIU/ML. IT WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS <0.1 MIU/ML. PATIENT TWO HAD AN INITIAL HCGB RESULT OF 37.9 MIU/ML. IT WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS <0.1 MIU/ML. PATIENT THREE, A (B)(6) FEMALE, HAD INITIAL HCGB RESULT OF 163.1 MIU/ML. IT WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS <0.1 MIU/ML. PATIENT FOUR, A (B)(6) FEMALE, HAD AN INITIAL HCGB RESULT OF 2336 MIU/ML. IT WAS REPEATED ON ANOTHER E602 ANALYZER AND THE RESULT WAS 8.3 MIU/ML. ON (B)(6) 2013, THE THIRD REPEAT FROM THE OTHER ANALYZER WAS 8.32 MIU/ML. ON (B)(6) 2013, THE FOURTH REPEAT FROM THE OTHER ANALYZER WAS 8.18 MIU/ML. ON (B)(6) 2013, THE ORIGINAL ANALYZER WAS CALIBRATED AND THE FOUR PATIENTS' SAMPLES WERE REPEATED WITH RESULTS CONSISTENT WITH THE REPEAT RESULTS FROM THE SECOND ANALYZER. THE REPEAT TESTING WAS PERFORMED ON THE OTHER E602 ANALYZER ON (B)(6) 2013. PATIENT 32 RECEIVED AN ULTRASOUND, BUT WAS NOT HARMED. THERE WERE NO ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS 169563 AND THE EXPIRATION DATE WAS NOT PROVIDED. ON (B)(6) 2013, A SUCCESSFUL PERFORMANCE TEST WAS RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212535 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1