BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2142932 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01842
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 15, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT'S WIFE REPORTED THE PT IS EXPERIENCING INSULIN LEAKAGE FROM THE INFUSION SITE (COMPETITOR PRODUCT) AND THE HEADSETS ARE NOT STICKING TO HIS BODY. HIS BLOOD GLUCOSE HAS ELEVATED TO AS HIGH AS 535 MG/DL AS A RESULT. HIS TARGET BLOOD GLUCOSE RANGE IS 150-180 MG/DL. SYMPTOMS OF ELEVATED BLOOD GLUCOSE ARE SWEATING AND HEADACHE. HE CHANGED THE INFUSION SITE IN AN ATTEMPT TO LOWER HIS BLOOD GLUCOSE. THE WIFE STATED THAT THE LAST TIME THE PT'S BLOOD GLUCOSE WAS THIS ELEVATED DUE TO THE LEAKY INFUSION SETS, SHE CALLED AN AMBULANCE (DATE OF EVENT NOT PROVIDED). HIS BLOOD GLUCOSE MEASURED 535 MG/DL AND THE PT WAS GIVEN A SHOT OF INSULIN AND HE WAS PLACED ON AN IV WHEN HE ARRIVED AT THE HOSPITAL. HE WAS RELEASED FROM THE HOSPITAL AFTER 10 HOURS AND INSTRUCTED TO CONTACT HIS HEART DOCTOR. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    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 68 YR Hospitalization| O| R INSULIN INFUSION SET| INSULIN