BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2457288 · Received February 16, 2012

    Report

    Report Number
    2531779-2012-01204
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 11, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE OF NORMAL USE WAS OBSERVED IN THE PUMP BLACK BOX OR DOWNLOAD HISTORY. DURING THE LOAD STEP THE PUMP DID NOT DETECT THE FILLED CARTRIDGE. A FORCE SENSOR CALIBRATION TEST SHOWED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION. THE PUMP WAS OPENED AND CONTAMINATION WAS FOUND IN THE FORCE SENSOR ASSEMBLY. FLOW ACCURACY TESTING WAS UNABLE TO BE COMPLETED DUE TO THE PUMP BEING UNABLE TO LOAD A CARTRIDGE. CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT REPORTED EXPERIENCING A BLOOD GLUCOSE OF 26 MMOL/L WITH INCREASED THIRST, FREQUENT URINATION, AND TIREDNESS. THE PATIENT REPORTED BOLUSED TO CORRECT FOR ELEVATED BLOOD GLUCOSE AND DROPPED TO 2.3 MMOL/L. THE PATIENT REPORTED TREATING WITH ORAL CARBOHYDRATE AND TEMPORARILY DECREASED BASAL RATE AND BLOOD GLUCOSE LEVELS RESOLVED. CUSTOMER SUPPORT ADVISED THE PATIENT TO DISCUSS SITE ROTATION WITH A HEALTH CARE PROVIDER AS THE PATIENT WAS USING ONLY THE ABDOMEN FOR INFUSION SITES. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY.

    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 30 YR