BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FOLATE III

    MDR report key: 12636199 · Received October 14, 2021

    Report

    Report Number
    1823260-2021-02999
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 16, 2021
    Report Date
    October 14, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGN
    PMA / PMN Number
    K082340
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER STATED THAT THEY PERFORMED ANOTHER COMPARISON STUDY WITH A SECOND SITE USING THE SAME NEW REAGENT LOT (536855) AND RESULTS SHOWED GOOD COMPARABILITY. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RAN 24 PATIENT SAMPLES AND RECEIVED DISCREPANT RESULTS FOR TWELVE PATIENT SAMPLES TESTED WITH THE ELECSYS FOLATE III ASSAY ON AN UNKNOWN ROCHE ANALYZER. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO UNITS OF MEASURE WERE PROVIDED. THE PATIENT SAMPLES WERE INITIALLY TESTED USING FOLATE REAGENT LOT 501636. THE SAMPLES WERE REPEATED USING NEW FOLATE REAGENT LOT 536855 AS PART OF A COMPARISON STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529824 ELECSYS FOLATE III ACID, FOLIC, RADIOIMMUNOASSAY CGN ROCHE DIAGNOSTICS NA 501636, 536855

    Patients

    Seq Age Sex Outcome Treatment
    1