BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLATE III

    MDR report key: 6050496 · Received October 24, 2016

    Report

    Report Number
    1823260-2016-01615
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    February 1, 2016
    Report Date
    November 14, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGN
    PMA / PMN Number
    K082340
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. FROM THE DATA PROVIDED, A GENERAL REAGENT ISSUE WAS NOT DETECTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED THE RESULTS RECEIVED FOR THE ELECSYS FOLATE III ASSAY FROM A COBAS E602 ANALYZER. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE GASTROENTEROLOGIST COMPLAINED TO THE LABORATORY THAT WITH THE NEW STANDARDIZATION AND NEW REFERENCES VALUES, A LOT OF PATIENTS ARE NOW CONSIDERED TO BE IN A CLINICAL STATUS OF "DEFICIENCY" WHEN THEY WERE CONSIDERED TO BE IN NORMAL RANGE WITH THE PREVIOUS FOLATE ASSAY. NO SPECIFIC PATIENT DATA WAS PROVIDED. THE PATIENTS WERE NOT ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704030 FOLATE III ACID, FOLIC, RADIOIMMUNOASSAY CGN ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1