BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3943589 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20586
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/17/2014 WITH THE FOLLOWING FINDINGS: THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT USER'S PROGRAMMED BASAL RATES. MULTIPLE OCCLUSION ALARMS OBSERVED IN THE BLACK BOX; THE FORCE AT TIME OF OCCLUSIONS IS HIGH. THE REWIND, LOAD CARTRIDGE, AND PRIME STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. THE FORCE SENSOR CALIBRATION TEST CONFIRMED SENSOR IS DETECTING CORRECT FORCE AT 5LBS. PUMP EXERCISED FOR 24 HOURS WITH NO OCCLUSIONS OCCURRING. THE PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. BATTERY CAP WAS UNAVAILABLE FOR TESTING; A TEST CAP WAS USED FOR ALL INVESTIGATION STEPS. 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.

    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 MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING FREQUENT/PERSISTENT OCCLUSION ALARMS. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 24MMOL/L. THE PATIENT DID NOT RECEIVE TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. THIS REPORT IS BEING MADE DUE TO BG EXCURSION THE PATIENT EXPERIENCED DUE TO AN ALLEGED OCCLUSION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422337 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening