BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2033421 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01866
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED AN EVAL WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT REPORTED THAT HIS BLOOD GLUCOSE LEVELS HAVE BEEN INTERMITTENTLY ELEVATED FOR A FEW WEEKS PRIOR TO CALLING ANIMAS. HE CANNOT CONFIRM WHETHER OR NOT INSULIN WAS LEAKING OUT OF HIS CARTRIDGES BUT THINKS IT'S A POSSIBILITY. THE PT'S BLOOD GLUCOSE LEVELS HAVE REPORTEDLY BEEN ELEVATED AROUND 300 MG/DL BUT DENIES KETONES OR SYMPTOMS. THE SITUATION IS NOT INDICATIVE OF A SERIOUS DIABETIC INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200/1250/2020/OTP B201582

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR