BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IL 6

    MDR report key: 11840589 · Received May 18, 2021

    Report

    Report Number
    1823260-2021-01477
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 26, 2021
    Report Date
    June 11, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    QLC
    PMA / PMN Number
    EUA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S CALIBRATION RESULTS WERE OK BUT LOWER THAN THE EXPECTED RANGES. THE CUSTOMER'S QC RESULTS FROM (B)(6)2021 WERE OK. THE INVESTIGATION REVIEWED THE SYSTEM'S ALARM TRACE AND NO CRITICAL ALARMS WERE DISCOVERED. TWO PATIENT SAMPLES WERE PROVIDED FOR AN INVESTIGATION. THE INVESTIGATION DISCOVERED THE PATIENT'S SAMPLE COLLECTED ON (B)(6)2021 WAS HEMOLYTIC. THE INVESTIGATION TESTED THE PROVIDED SAMPLES AND THE CUSTOMER'S RESULTS WERE REPRODUCED. NO INTERFERING FACTOR WAS FOUND IN EITHER OF THE PROVIDED SAMPLES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE DEVICE IDENTIFIER (UDI) (B)(4). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS IL 6 RESULTS FOR ONE PATIENT TESTED ON A COBAS E411 DISK SERIAL NUMBER (B)(4). THE PATIENT'S INITIAL IL SIX (6) RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING WITH A VECTOR-BEST ELISA ANALYZER AND THE COBAS E411 DISK. ON (B)(4) 2021, THE PATIENT'S ELECSYS INITIAL IL SIX (6) RESULT WAS 1.50 PG/ML WITH A DATA FLAG. THE PATIENT'S IL 6 RESULT WITH THE SAME SAMPLE ON THE VECTOR-BEST ELISA ANALYZER WAS 300 PG/ML. ON (B)(6) 2021, THE PATIENT'S REPEAT ELECYS IL SIX (6) RESULT WITH THE SAME SAMPLE ON THE COBAS E411 DISK WAS 1.77 PG/ML. ON (B)(6) 2021, THE PATIENT HAD A NEW SAMPLE COLLECTED AND THE PATIENT'S ELECSYS IL SIX (6) RESULT ON A COBAS E411 DISK WAS 2.60 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736294 ELECSYS IL 6 INTERLEUKIN 6 QLC ROCHE DIAGNOSTICS IL-6 49651501

    Patients

    Seq Age Sex Outcome Treatment
    1