BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 4162046 · Received October 10, 2014

    Report

    Report Number
    1823260-2014-07787
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 27, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULT FOR ONE PATIENT ON THEIR E601 ANALYZER. THE PATIENT'S INITIAL HCGB RESULT WAS 54.20 MIU/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT THEN WENT TO THE HOSPITAL TO CONFIRM WHETHER SHE WAS PREGNANT, BUT THE CLINICIAN TOLD HER SHE WAS NOT POSITIVE FOR HCGB. ON (B)(6) 2014, THE CUSTOMER DECIDED TO REPEAT THE SAMPLE. THE RESULTS WERE 0.100 IU/L ACCOMPANIED BY A DATA FLAG AND 0.100 MIU/ML ACCOMPANIED BY A DATA FLAG. THE CUSTOMER ALSO PROVIDED AN HCGB RESULT FROM "SEROTHEQUE", CLARIFICATION OF THIS SAMPLE WAS NOT PROVIDED. THE RESULT WAS 0.100 MIU/ML ACCOMPANIED BY A DATA FLAG. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE HCGB REAGENT LOT NUMBER WAS 180039. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE. HE CHECKED THE ANALYZER AND IT WAS CLEAN. THERE WERE NO PROBLEMS FOUND. A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE QUALITY CONTROL WAS WITHIN SPECIFICATIONS. BASED ON THE AVAILABLE DATA, A GENERAL ANALYZER OR REAGENT ISSUE WAS UNLIKELY, BUT COULD NOT BE EXCLUDED. IT WAS NOTED THE CUSTOMER WAS NOT FOLLOWING THE TUBE MANUFACTURER'S CENTRIFUGATION RECOMMENDATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643141 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 029 YR INTRAUTERINE DEVICE