BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2982059 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00184
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE ALARM FUNCTIONS OF THE INSULIN PUMP WERE TESTED WITHIN THE ALARM FUNCTION TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT HAS EXPERIENCED HYPERGLYCEMIA OF UP TO 400 MG/DL FOR 10 DAYS, AND SHE BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW. SHE HAS CHANGED THE INFUSION SET AND DELIVERED BOLUSES OF 2-3 UNITS EVERY 3 HOURS, BUT HER BLOOD GLUCOSE HAS REMAINED ELEVATED. SHE IS CAREFUL TO FOLLOW HER TREATMENT AND MEAL PLAN, AND THE INFUSION DEVICE HAS NOT PROVIDED AN ALERT/ERROR MESSAGE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. SHE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55372 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES