BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS MYOGLOBIN

    MDR report key: 21130040 · Received January 10, 2025

    Report

    Report Number
    1823260-2025-00107
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 14, 2024
    Report Date
    February 19, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DDR
    PMA / PMN Number
    K083260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE PROVIDED CALIBRATION AND QC DATA, A GENERAL INSTRUMENT AND REAGENT ISSUES WERE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE COBAS E411 DISK SERIAL NUMBER WAS (B)(6). SAMPLE 1 AND SAMPLE 2 WERE CLEAR IN APPEARANCE, WITH NO HEMOLYSIS OR LIPEMIA. THE FIELD SERVICE ENGINEER CHECKED THE SERUM QUALITY AT THE CUSTOMER'S SITE AND FOUND NO ABNORMALITIES. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM SAMPLES TESTED WITH ELECSYS MYOGLOBIN (MYO) ASSAY TESTED ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM). SAMPLE 1 AND SAMPLE 2 WERE COLLECTED AT THE SAME TIME. SAMPLE 1 (BLOOD COLLECTION TUBE 1): MYO: INITIAL RESULT: 98.23 NG/ML (EXCEEDING THE NORMAL REFERENCE VALUE). REPEAT RESULT: 99.57 NG/ML. SAMPLE 2 (BLOOD COLLECTION TUBE 2): MYO: INITIAL RESULT: 33.71 NG/ML. REPEAT RESULT: 34.36 NG/ML. SAMPLE 1 AND SAMPLE 2 WERE THEN RE-TESTED ON A JOHNSON AND JOHNSON INSTRUMENT AND THE MYO RESULTS WERE CONSISTENT WITH THE RESULTS OBTAINED FROM THE E411 DISK SYSTEM. SAMPLE 1 AND SAMPLE 2 WERE RE-TESTED FOR CK ON A BECKMAN INSTRUMENT: SAMPLE 1: CK RESULTS: 200.2 U/L. SAMPLE 2: CK RESULTS: 144 U/L. A NEW BLOOD SAMPLE (SAMPLE 3) WAS WITHDRAWN FROM THE PATIENT AND TESTED RESULTING IN THE FOLLOWING VALUES: MYO: 39.07 NG/ML (WITHIN THE NORMAL REFERENCE RANGE). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511545 ELECSYS MYOGLOBIN MYOGLOBIN IMMUNOLOGICAL TEST SYSTEM DDR ROCHE DIAGNOSTICS 81511201

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Unknown