BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3012307 · Received March 20, 2013

    Report

    Report Number
    2531779-2013-02836
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/10/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY REVEALED THAT THE LAST BASAL AND BOLUS DELIVERY WAS ON (B)(6) 2013. THERE WERE NO ALARMS OUTSIDE OF NORMAL PATIENT USE OBSERVED IN THE PUMP HISTORY. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. NO ALARMS OCCURRED DURING TESTING. 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. 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) 2013, THE PATIENT CONTACTED ANIMAS STATING SHE EXPERIENCED ISSUES WITH LOW BLOOD GLUCOSE (BG). THE PATIENT'S BG WAS REPORTEDLY IN THE RANGE OF 1.3MMOL/L TO 3.9MMOL/L WITH FATIGUE. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP HISTORY AND THERE WERE NO ALARMS NOTED AND THE BASAL AND BOLUS AMOUNT DELIVERED WERE FOUND TO BE CORRECT. CS ADVISED THE PATIENT TO CONTACT THE HEALTH CARE PROVIDER (HCP) FOR ASSISTANCE IN ADJUSTING THE PUMP'S SETTINGS. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT EXPERIENCING A HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. IT WAS UNKNOWN WHAT CAUSED THE PATIENT'S LOW BGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116498 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR