BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS IL 6

    MDR report key: 10407342 · Received August 14, 2020

    Report

    Report Number
    1823260-2020-01995
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 14, 2020
    Report Date
    October 19, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    QLC
    PMA / PMN Number
    EUA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S CALIBRATION WAS OK. THE CUSTOMER'S QC INFORMATION FROM THE DATES OF TESTING WAS REQUESTED BUT NOT PROVIDED. THE SAMPLE CLOTTING TIME WAS INSUFFICIENT ACCORDING TO THE TUBE MANUFACTURER'S RECOMMENDATIONS. 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). THE PATIENT'S SAMPLE WAS REQUESTED FOR INVESTIGATION, BUT THE SAMPLE WAS NOT AVAILABLE. 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 6000 E 601 MODULE SERIAL NUMBER (B)(4). THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2020, THE PATIENT¿S INITIAL IL 6 RESULT WAS 791.3 PG/ML. ON (B)(6) 2020, THE CUSTOMER REPEATED THE INITIAL SAMPLE AT 13:36 AND THE PATIENT'S IL 6 RESULT WAS 406.3 PG/ML. AT 13:38, THE PATIENT'S IL 6 RESULT FROM A NEW DRAW WAS 205.1 PG/ML. ON (B)(6) 2020, THE PATIENT'S IL 6 RESULT FROM A NEW DRAW WAS 18.2 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870227 ELECSYS IL 6 INTERLEUKIN 6 QLC ROCHE DIAGNOSTICS IL-6 43676102

    Patients

    Seq Age Sex Outcome Treatment
    1