BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4122816 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27687
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/11/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/20/2016 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DATA FROM THE DATE OF THE EVENT HAD BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. THE INITIAL ALLEGATION COULD NOT BE VERIFIED. THE AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER'S PROGRAMMED BASAL RATES. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED RANGE. A 10U AUDIO AND A 10U NORMAL BOLUS WERE PERFORMED SUCCESSFULLY AND ACCURATELY RECORDED IN THE PUMP HISTORY. NO HYPERSENSITIVE KEYS WERE OBSERVED ON THE KEYPAD. UNRELATED TO THE INITIAL ALLEGATION, THE DISPLAY SCREEN WAS DISCOLORED. THE BATTERY COMPARTMENT WAS CRACKED. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT REQUIRED TO BE 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 A HYPOGLYCEMIC EVENT ASSOCIATED WITH PUMP USE. THE REPORTER STATED THAT ON (B)(6) 2014, THE PATIENT'S BLOOD GLUCOSE (BG) WAS 48MG/DL WITH SYMPTOMS OF HUNGER, FATIGUE, CONFUSION AND DISORIENTATION AFTER ANOTHER PERSON INADVERTENTLY BOLUSED THE PATIENT WITH 2.25U TWICE IN A ROW. REPORTEDLY, NO TREATMENT WAS PROVIDED ABOVE AND BEYOND USUAL DIABETES MANAGEMENT, THE PATIENT'S HEALTHCARE PROVIDER HAD NOT MADE PUMP SETTING ADJUSTMENTS BEFORE OR AFTER THE ALLEGED EVENT, AND THE PATIENT REMAINED ON THE PUMP. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED HYPOGLYCEMIA DURING PUMP USE FOR WHICH IT WAS DETERMINED THAT PUMP USE ERROR WAS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601593 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Life Threatening