BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOKERATIN FRAGMENTS 21-1 EIA KIT

    MDR report key: 9878349 · Received March 25, 2020

    Report

    Report Number
    1823260-2020-00838
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    February 15, 2020
    Report Date
    April 14, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    OVK
    PMA / PMN Number
    K160915
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QC RESULTS DO NOT INDICATE A REAGENT ISSUE. THE CUSTOMER COULD NOT PROVIDE THE PATIENT'S SAMPLE FOR FURTHER TESTING TO COMPLETE THE INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT OR INSTRUMENT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE FIELD SERVICE ENGINEER DID NOT IDENTIFY A PRODUCT PROBLEM. HE RECOMMENDED THE CUSTOMER USE A NEW REAGENT CASSETTE AND PERFORM CALIBRATION AND QC WITH FRESH MATERIALS. THE FIELD APPLICATIONS SPECIALIST PERFORMED A PRECISION CHECK.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE CYFRA 21-1 ELECSYS RESULTS FOR ONE PATIENT ON A COBAS E411 RACK SERIAL NUMBER (B)(4) AND A COBAS 8000 E 801 MODULE, SERIAL NUMBER REQUESTED BUT NOT PROVIDED. THE INITIAL RESULTS FROM AN E411 WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER SENT THE PATIENT¿S SAMPLE TO ANOTHER LABORATORY FOR REPEAT TESTING ON AN E 801.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340879 CYTOKERATIN FRAGMENTS 21-1 EIA KIT TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM. OVK ROCHE DIAGNOSTICS NA 422890

    Patients

    Seq Age Sex Outcome Treatment
    1