BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER

    MDR report key: 5978034 · Received September 26, 2016

    Report

    Report Number
    1823260-2016-01466
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    August 26, 2016
    Report Date
    October 18, 2016
    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

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: ASKU.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. GENERAL ROOT CAUSES OF THIS TYPE OF EVENT INCLUDE INSUFFICIENT ELECTROMAGNETIC INTERFERENCE (EMI) COMPLIANCE BY THE LABORATORY, ISSUES WITH THE SAMPLE QUALITY, INSUFFICIENT MAINTENANCE, AND CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULT FOR ONE PATIENT SAMPLE. (B)(6). THESE RESULTS WERE GENERATED IN ANOTHER LABORATORY AND THERE WAS NO INFORMATION ABOUT THE METHODOLOGY. THE CUSTOMER STATED THAT THE PATIENT HAD AN ABORTION A "FEW DAYS AGO". THE SPECIFIC DATE WAS NOT PROVIDED. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 190280. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627861 ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E MODULE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR