BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1881019 · Received October 18, 2010

    Report

    Report Number
    2531779-2010-01723
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 18, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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 FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: NO DATA IN THE BLACK BOX OR DOWNLOAD HISTORIES FROM THE TIME OF THE REPORTED HIGH BG DUE TO CONTINUED PATIENT USE. DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING INSULIN WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE USER GUIDE INSTRUCTS THE PATIENT THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    ACCORDING TO THE PATIENT'S FATHER, THE PATIENT HAD UNEXPLAINABLE LOW BLOOD FOR 1.5 DAYS, WHICH STARTED ON (B)(6), 2010 AT 8:10PM. DURING THE 1.5 DAYS, THE PATIENT OBTAINED LOW BLOOD GLUCOSE RESULTS SUCH AS 42, 44, 51, 53, AND 70 MG/DL. THE PATIENT WAS REPORTEDLY SLIGHTLY LETHARGIC AT "41 MG/DL" BUT UNDERSTOOD COMMANDS AND WAS NOT INCOHERENT OR UNCONSCIOUS. IT WAS NOTED THAT THE LOW BLOOD GLUCOSE EVENTS WERE TREATED; HOWEVER, DETAILS OF THE TREATMENT WERE NOT PROVIDED. THE PATIENT'S FATHER CONTACTED THE PATIENT'S HEALTH CARE PROFESSIONAL FOR ADVICE: THE PATIENT'S FATHER WAS ADVISED TO CONTACT ANIMAS TO TROUBLESHOOT THE PUMP. THE ANIMAS REPRESENTATIVE HELPED THE PATIENT'S FATHER REVIEW THE PUMP'S DATE/TIME SETTINGS, ALARM HISTORY, BASAL AND BOLUS DELIVERY HISTORY AND THE PATIENT'S FATHER CONFIRMED THAT THEY WERE ALL CORRECT. THE PATIENT REPORTEDLY HAS NOT DECREASED CARBOHYDRATE INTAKE OR HAD ANY INCREASED ACTIVITY LEVELS. THE ANIMAS REPRESENTATIVE ADVISED THE REPORTER TO CONTACT THE PATIENT'S DOCTOR REGARDING THE HYPOGLYCEMIC EVENTS AND FOR POSSIBLE INSULIN ADJUSTMENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention