BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3922382 · Received July 9, 2014

    Report

    Report Number
    1823260-2014-05024
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 28, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT NOT PROVIDED. THE CALIBRATION WAS WITHIN RANGE, BUT LOW FOR CALIBRATOR 2. THE ROCHE QUALITY CONTROL WAS WITHIN SPECIFICATIONS ON THE DAY OF THE EVENT, BUT THE CUSTOMER'S OWN QUALITY CONTROL MATERIAL WAS OUT OF RANGE ON SOME DAYS. THERE WAS NO REAGENT ISSUE EVIDENT. THE PATIENT'S SAMPLE WAS MEASURED IN A SECONDARY TUBE WITH AN INNER DIAMETER SMALLER THAN RECOMMENDED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULTS ON THEIR E601 ANALYZER. THE SAMPLES WERE PROCESSED BY THE CUSTOMER'S RSA PRE-ANALYTICAL DEVICE. THE FIRST PATIENT'S INITIAL HCGB RESULT WAS 0.259 MIU/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 0.284 MIU/ML ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2014, THE FIRST PATIENT'S SAMPLE WAS REPEATED AND THE RESULTS WERE 42.89 MIU/ML ACCOMPANIED BY A DATA FLAG AND 41.48 MIU/ML ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2014, THE SECOND PATIENT, A (B)(6) FEMALE, HAD AN INITIAL HCGB RESULT OF 2.87 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SECOND PATIENT'S SAMPLE WAS REPEATED AND THE RESULTS WERE 482.2 MIU/ML ACCOMPANIED BY A DATA FLAG AND 481.9 MIU/ML ACCOMPANIED BY A DATA FLAG. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE AND REPLACED THE MEASURING CELL. ON (B)(6) 2014, THE THIRD PATIENT, A (B)(6) FEMALE, HAD AN INITIAL HCGB RESULT OF 19.44 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AND THE RESULT WAS 1282 MIU/ML ACCOMPANIED BY A DATA FLAG. THE POSITIVE HCGB RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS 175098. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399692 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 040 YR