BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2992634 · Received March 7, 2013

    Report

    Report Number
    2531779-2013-02469
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4)-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT THE LAST BASAL DELIVERY OCCURRED ON (B)(4) 2013 AT 6:33PM. 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. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE PUMP WAS SUCCESSFULLY PAIRED WITH A TEST METER. PERIODIC BOLUSES WERE EXECUTED DURING TESTING USING THE NORMAL, EZCARB, EZBG, AND COMBO BOLUS FEATURES AND ALL BOLUSES ACCURATELY RECORDED IN THE PUMP HISTORY. THE KEYPAD WAS INSPECTED AND NO DAMAGE WAS OBSERVED; ALL KEYPAD BUTTONS WERE FOUND TO BE RESPONDING APPROPRIATELY. THERE WAS NO DEFECT FOUND ON INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING BLOOD GLUCOSE LEVELS IN THE 400 MG/DL RANGE WITH STOMACH SYMPTOMS. THE PATIENT REPORTED BOLUSING AND THE ELEVATED BLOOD GLUCOSE RESOLVED. THE PATIENT CONFIRMED THE PUMP SETTINGS WERE ACCURATE. THE PATIENT WAS UNABLE TO CONFIRM THE BOLUS HISTORY AS THE PATIENT COULD NOT REMEMBER WHEN THE EVENTS OCCURRED. 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
    97901 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening