BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2260577 · Received September 22, 2011

    Report

    Report Number
    1823260-2011-05033
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    June 27, 2011
    Report Date
    October 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURED IN THE (B)(6).

    Additional Manufacturer Narrative · 1

    INSUFFICIENT INFORMATION WAS PROVIDED FOR FURTHER INVESTIGATION. A ROOT CAUSE COULD NOT BE DETERMINED. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT. IT IS UNKNOWN IF THERE WERE ANY ADVERSE EFFECTS TO THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT RESULT (HCG+B) RESULT ON THEIR MODULAR E ANALYZER. THE PATIENT'S INITIAL HCG+B RESULT WAS 30 U/L. THE ANALYZER AUTOMATICALLY REPEATED THE SAMPLE AND THE RESULT WAS 2 U/L. THE CUSTOMER ANALYZED THE SAMPLE ON ANOTHER SYSTEM AND THE RESULT WAS ALSO 2 U/L. INFORMATION REGARDING THE OTHER SYSTEM USED FOR TESTING WAS NOT PROVIDED. THE INCORRECT RESULTS GENERATED BY THE ANALYZER WAS NOT REPORTED BECAUSE THE ANALYZER WAS PROGRAMMED TO AUTOMATICALLY RERUN INCREASED "LEVELS". THE HCG+B LOT NUMBER WAS 158905. THE FIELD SERVICE SPECIALIST REPLACED THE MEASURING CELL. NO MORE "OUTLIERS" HAVE BEEN SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR