BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3062501 · Received April 17, 2013

    Report

    Report Number
    2531779-2013-04380
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: THE PUMP EMITTED A CALL SERVICE ALARM EARLY THIS MORNING. PATIENT CLEARED ALARM BY REBOOTING PUMP AND CHANGING CARTRIDGE AND INFUSION SET PRIOR TO CALLING ANIMAS. AT TIME OF CALL, CALL SERVICE ALARM HAD BEEN RESOLVED. PATIENT BELIEVED THAT SHE IS NOT GETTING ANY INSULIN AND REPORTS A BLOOD GLUCOSE OF 431MG/DL THIS MORNING AND AT TIME OF CALL BG LEVEL WAS REPORTED AT APPROXIMATELY 510MG/DL. PATIENT REPORTS NO PERTINENT SYMPTOMS OTHER THAN SHE KNOWS WHEN SHE IS RUNNING HIGH. AT TIME OF CALL, PATIENT HAD ALREADY COMPLETED A BOLUS AND WOULD BE RECHECKING HER BLOOD GLUCOSE LEVELS IN 2 HOURS. ANIMAS LATER CALLED PATIENT BACK, AND HER BG WAS DOWN TO 397 MG/DL. SHE REPORTED SYMPTOMS OF THIRST AND A "WEIRD FEELING IN HANDS" THAT SHE GETS WHEN BG IS HIGH. PUMP HAS NOT ALARMED SINCE CLEARING 064 ALARM. CUSTOMER TECHNICAL SUPPORT (CTS) EXPLAINED ALARM AND REVIEWED BOLUS HISTORY WITH THE PATIENT AND FOUND THE INSULIN WAS INFUSING. PATIENT UNDERSTANDS IOB WHEN CORRECTING BG ISSUE AND IS AWARE THAT 2 UNIT AIR BOLUS IS IN IOB. THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT ON PUMP THERAPY EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166235 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening