BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2727073 · Received September 5, 2012

    Report

    Report Number
    2531779-2012-09850
    Event Type
    Injury
    Date Received
    September 5, 2012
    Report Date
    August 1, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ON (B)(6) 2012, THE REPORTER (PATIENT'S MOM) CONTACTED ANIMAS REPORTING THAT THE PATIENT'S BLOOD GLUCOSE (BG) HAD BEEN HIGH FOR THE LAST 4 DAYS RANGING FROM 200-433 MG/DL AND REPORTEDLY HAD LARGE KETONES WITH SYMPTOMS OF NAUSEA AND VOMITING ON (B)(6) 2012. THE REPORTER STATED THAT THE PATIENT'S BG RESPONDED WITH INJECTIONS WITH THE SAME INSULIN USED WITH THE INSULIN PUMP BUT HIS BG'S DO NOT WITH THE INSULIN PUMP. THE PATIENT DID NOT HAVE ANY ILLNESSES AT THE TIME. THE REPORTER CLAIMED THERE ARE NO REPORTED ISSUES WITH THE INFUSION SET, SITES, AND CARTRIDGE. THE PUMP SETTINGS (ADVANCED FEATURES AND BASAL SETTINGS) WERE CONFIRMED TO BE SET AS INTENDED. THROUGH TROUBLESHOOTING ON THE PHONE, THE ANIMAS CUSTOMER SUPPORT DID NOT FIND ANY MECHANICAL ISSUES WITH THE PUMP. ALTHOUGH TROUBLESHOOTING DID NOT FIND ANY INDICATION OF A PUMP MALFUNCTION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED ELEVATED BG LEVELS FOR 4 DAYS WHILE USING THE PUMP. THE PATIENT'S BG'S WERE REPORTEDLY RESPONDING WITH INJECTIONS BUT NOT WITH THE INSULIN PUMP. THE REPORTER REFUSED TO RETURN THE PUMP TO ANIMAS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening| R