BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3840400 · Received May 30, 2014

    Report

    Report Number
    1823260-2014-03871
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DATA WERE REQUESTED BUT NOT PROVIDED. THE PROVIDED QUALITY CONTROL RESULTS WERE WITHIN SPECIFICATION. IT WAS NOTED THE CUSTOMER WAS NOT PERFORMING QUALITY CONTROL ON EACH REAGENT PACK SEPARATELY AS RECOMMENDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION. THE RESULT OF 2134 MIU/ML WAS NOT AN ACTUAL PATIENT RESULT.

    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 E- MODULE. THE PATIENT'S INITIAL HCGB RESULT WAS 0.100 MIU/ML ACCOMPANIED BY A DATA FLAG AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT DOUBTED THE RESULT. ON (B)(6) 2014, THE SAMPLE WAS REPEATED ON THE ORIGINAL E-MODULE. THE RESULT WAS 2131 MIU/ML ACCOMPANIED BY A DATA FLAG. THE CUSTOMER ALSO PROVIDED THE RESULT 2134 MIU/ML. CLARIFICATION ON WHAT THIS RESULT WAS HAS BEEN REQUESTED. ON (B)(6) 2014, THE SAMPLE WAS TESTED ON ANOTHER E-MODULE AND THE RESULT WAS 2146 MIU/ML ACCOMPANIED BY A DATA FLAG. THERE WERE NO DEATHS, INJURIES, ILLNESSES, OR DETERIORATIONS IN HEALTH ASSOCIATED WITH THE ERRONEOUS RESULTS. INFORMATION ON WHETHER THE PATIENT WAS HARMED BY ANY ACTION TAKEN WAS REQUESTED BUT NOT PROVIDED. THE HCGB REAGENT LOT NUMBER WAS 173268. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318662 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR