BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1942532 · Received December 22, 2010

    Report

    Report Number
    2183996-2010-02663
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2010, SHE WENT TO THE GYM AND HER BLOOD GLUCOSE NORMALLY DECREASES. ON (B)(6) 2010 AT 12:38AM, HER BLOOD GLUCOSE MEASURED 374 MG/DL. SHE BOLUSED 4 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. AT 1:48AM, HER BLOOD GLUCOSE MEASURED 383 MG/DL AND SHE BOLUSED 3 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. SHE WENT TO BED AND WOKE UP DUE TO A STOMACH ACHE. HER BLOOD GLUCOSE MEASURED 410 MG/DL AT 2:25AM. SHE DISCONNECTED FROM THE INFUSION SITE AND BOLUSED AND FOUND INSULIN WAS NOT BEING CORRECTLY DELIVERED. SHE CHANGED THE INSULIN CARTRIDGE, INFUSION SITE AND TUBING AND BOLUSED 4 UNITS OF INSULIN. SHE STATED THAT THE INFUSION DEVICE IS WORKING BUT SHE STILL EXPERIENCES ISSUE WITH HER BLOOD GLUCOSE. SHE STATED PRIMING IS SLOW AND THERE MAY BE AN ISSUE WITH THE PISTON ROD. HER NORMAL BLOOD GLUCOSE RANGE IS 130-140 MG/DL. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION SET