BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS INSULIN

    MDR report key: 3578646 · Received January 16, 2014

    Report

    Report Number
    1823260-2014-00358
    Event Type
    Malfunction
    Date Received
    January 16, 2014
    Date of Event
    November 19, 2013
    Report Date
    February 7, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. THE CUSTOMER STATED THE SAMPLE WAS A LITTLE HEMOLYTIC. THE INSULIN ASSAY IS KNOWN TO BE VERY SENSITIVE TO HEMOLYSIS IN PATIENT SAMPLES. THIS LIMITATION IS COVERED IN THE PACKAGE INSERT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE INSULIN RESULTS ON THEIR E411 ANALYZER FOR ONE PATIENT. THE PATIENT'S INITIAL INSULIN RESULT WAS 38.20 MIE/L ACCOMPANIED BY A DATA FLAG AND IT WAS REPORTED TO THE WARD. THE SAMPLE WAS ANALYZED AGAIN AND THE RESULT WAS 6.5 MIE/L AND IT WAS ALSO REPORTED TO THE WARD. ON (B)(6) 2013, THE SAMPLE WAS REPEATED IN TRIPLICATE AND THE RESULTS WERE 1.95 MIE/L, 1.93 MIE/L, AND 1.96 MIE/L AND ALL THREE RESULTS WERE ACCOMPANIED BY DATA FLAGS. NONE OF THESE RESULTS WERE REPORTED TO THE WARD. THE SAMPLE WAS THEN REPEATED AGAIN THAT DAY AND THE RESULTS WERE 1.70 MIE/L, 1.76 MIE/L, AND 2.02 MIE/L ACCOMPANIED BY A DATA FLAG. NONE OF THESE RESULTS WERE REPORTED TO THE WARD. INFORMATION ON WHETHER THERE WERE ANY ADVERSE EVENTS WAS REQUESTED BUT NOT PROVIDED. THE INSULIN REAGENT LOT NUMBER WAS 172706. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42974 ELECSYS INSULIN INSULIN JJE ROCHE DIAGNOSTICS NA 172706

    Patients

    Seq Age Sex Outcome Treatment
    1 018 YR