BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3854961 · Received June 9, 2014

    Report

    Report Number
    2531779-2014-16132
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN REQUESTED FOR RETURN AT THIS TIME. 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) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A HYPERGLYCEMIC EVENT ASSOCIATED WITH ALLEGED LOSS OF PRIME ISSUE. THE REPORTER STATED THAT A LOSS OF PRIME WARNING HAD OCCURRED 3 OR MORE TIMES OVER SEVERAL MONTHS. REPORTEDLY, THE PATIENT¿S BLOOD GLUCOSE WAS BETWEEN 200-550 MG/DL WITH NO SYMPTOMS AND NO KETONES REPORTED. IT WAS REPORTED THAT THE PATIENT HAD NOT RECEIVED ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT, THE PATIENT¿S HEALTHCARE PROVIDER HAD NOT ADJUSTED THE PUMP SETTINGS BEFORE OR AFTER THE ALLEGED EVENT, AND THE PATIENT REMAINED ON THE PUMP. TROUBLESHOOTING DETERMINED THAT THE REWIND, LOAD AND PRIME STEPS WERE SUCCESSFULLY COMPLETED, AND THERE WERE NO ASSOCIATED ALARMS IN THE ALARM HISTORY. TROUBLESHOOTING DETERMINED THAT THE PATIENT HAD BEEN USING EXPIRED CARTRIDGES. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED HYPERGLYCEMIA ASSOCIATED WITH USE ERROR OF THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336566 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION D201386

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening