BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2032291 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01846
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER, THE PT'S MOTHER, REPORTED TWO INSULIN CARTRIDGES WERE LEAKING AND ON (B)(6) 2011, THE PT OBTAINED A BLOOD GLUCOSE READING OF 'HI MG/DL' (GREATER THAN 600 MG/DL). THE PT DID NOT REPORT EXPERIENCING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PT WAS TAKEN TO THE EMERGENCY ROOM, WHERE HER BLOOD GLUCOSE LEVEL WAS TESTED TO BE 800 MG/DL, AND SHE REC'D TREATMENT. TROUBLESHOOTING REVEALED THE LEAK APPEARED TO BE IN THE TUBING CONNECTION SITE OF THE CARTRIDGE, THE LUER LOCK WAS SECURE AND THERE WAS NO VISIBLE DAMAGE TO THE CARTRIDGE OR TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORPORATION IR 1200/ 1250 / 2020/ OTP B55555

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| L| R