BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS FOLATE GEN 3

    MDR report key: 9686163 · Received February 10, 2020

    Report

    Report Number
    1823260-2020-00351
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    January 15, 2020
    Report Date
    March 12, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGN
    PMA / PMN Number
    K082340
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINED SAMPLE WAS NOT AVAILABLE TO BE RETURNED. THE PACKAGE INSERT STATES TO MEASURE AT A 1:2 DILUTION. WHEN DILUTING, DILUTE THE SAMPLE SO THAT THE ACTUAL CONCENTRATION OF THE DILUTED SAMPLE IS GREATER THAN 8.5 NG/ML. OTHER DILUTIONS MAY NOT BE LINEAR. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE COUNTRY OF ORIGIN IS (B)(6). THE SAMPLE WAS REQUESTED FOR RETURN.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FOLATE GEN 3 RESULTS, FOR 1 PATIENT, FROM A COBAS 8000 E 801 MODULE WITH AN UNKNOWN SERIAL NUMBER. THE FOLLOWING ARE RESULTS FROM THE PATIENT'S SAMPLE: INITIAL: >20 NG/ML. RERUN (DILUTION X5) : >100 NG/ML. RERUN (DILUCTION X50) : >1000 NG/ML. RERUN (DILUTION X900) : <540 NG/ML. RERUN (DILUTION X400) : 580 NG/ML. RERUN (DILUTION X100) : 973 NG/ML. IT WAS UNKNOWN IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153361 ELECSYS FOLATE GEN 3 FOLIC ACID TEST SYSTEM CGN ROCHE DIAGNOSTICS FOLATE G3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1