BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER

    MDR report key: 2087278 · Received May 12, 2011

    Report

    Report Number
    2531779-2011-03379
    Event Type
    Injury
    Date Received
    May 12, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: ANIMAS INSULIN CARTRIDGE. CATALOG #: 100-124-01. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER, THE PATIENT'S MOTHER, REPORTED THE PATIENT HAD OBTAINED SEVERAL "ELEVATED" BLOOD GLUCOSE READINGS AFTER SHE HAD NOTED LEAKING INSULIN AND THE PUMP SMELLED OF INSULIN. THE PATIENT'S PHYSICIAN REQUESTED THE INSULIN PUMP BE REPLACED. THE PATIENT DID NOT REPORT ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS AND DID NOT REPORT SEEKING ANY MEDICAL ATTENTION OR TREATMENT. THE PUMP WAS NOT AVAILABLE AT THE TIME OF THE CALL, THEREFORE NO TROUBLESHOOTING COULD BE DONE. NO INFORMATION WAS PROVIDED CONCERNING THE PATIENT'S SYMPTOMS OR TREATMENT. AS THE PATIENT REPORTED SEVERAL HIGH BLOOD GLUCOSE READINGS AFTER NOTING A LEAKING CARTRIDGE IN THE PUMP, AND AS THE PHYSICIAN REQUESTED THE PUMP BE REPLACED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTHER INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening