BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3980430 · Received August 5, 2014

    Report

    Report Number
    2531779-2014-22409
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/20/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED NO EVIDENCE OF A POWER ISSUE AND THERE WAS NO DAMAGE FOUND TO THE BATTERY COMPARTMENT OR THE RETURNED BATTERY CAP. THE RETURNED BATTERY CAP FIT TIGHTLY TO THE PUMP WITH NO VISIBLE YELLOW O RING SHOWING AND THE PUMP WAS THEN EXERCISED FOR 24 HOURS WITH NO POWER RESET EVENTS BEING DUPLICATED. THERE WAS NO EVIDENCE OF MOISTURE OBSERVED IN THE BATTERY COMPARTMENT AND THE PUMP PASSED A LEAK TEST. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED AND THE PUMP WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN REQUIRED RANGE. THE TOTAL DAILY DOSES ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATE. THE PUMP COVER WAS REMOVED FOR FURTHER INVESTIGATION AND THERE WAS NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT FOUND. PRODUCT ANALYSIS WAS UNABLE TO CONFIRM OR DUPLICATE THE INITIAL COMPLAINT. 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. 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) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT'S BLOOD GLUCOSE (BG) WAS 773MG/DL WITH LARGE KETONES AND SYMPTOMS OF RAPID, DEEP BREATHING/ SHORTNESS OF BREATH/CHEST PAIN THAT WAS TREATED IN AN EMERGENCY ROOM WITH INSULIN VIA INJECTION, IV FLUIDS, AND PUMP USE WAS DISCONTINUED. IT WAS REPORTED THAT THERE WERE NO PUMP SETTING CHANGES BEFORE OR AFTER THE ALLEGED EVENT AND THAT ON (B)(6) 2014, THE PUMP HAD BEEN REBOOTING INDICATING AN INTERMITTENT POWER ISSUE, WITH MOISTURE OR CORROSION IN THE BATTERY COMPARTMENT. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED HYPERGLYCEMIA ASSOCIATED WITH AN INTERMITTENT POWER ISSUE WITH MOISTURE INGRESS IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457351 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening| R