BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3953320 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21162
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    July 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/17/2014 WITH THE FOLLOWING FINDINGS: NO DAMAGE FOUND TO BATTERY COMPARTMENT. BATTERY CAP WAS NOT RETURNED. A NEW TEST BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP WITH NO YELLOW O RING SHOWING. THE PUMP WAS EXERCISED FOR 24HRS WITH NEW TEST BATTERY CAP, NO POWER INTERRUPTIONS WERE DUPLICATED. THE TOTAL DAILY DOSE ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATE. TYPICAL USAGE OBSERVED IN ALARM HISTORY. THE PUMP PASSED A DELIVERY ACCURACY TEST. THE PUMP COVER WAS REMOVED; NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT WAS FOUND. THE COMPLAINT WAS VERIFIED IN THE HISTORY BUT COULD NOT BE DUPLICATED DURING THE INVESTIGATION. THE DISPLAY SCREEN HAS A PINKISH CONTRAST. KEYPAD IS LIFTED UP NEAR THE OK KEY. A DAMAGED KEYPAD WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACTS NEGATIVELY IMPACTING THE BUTTON FUNCTION. THE DAMAGED KEYPAD IS OBVIOUS AND DETECTABLE AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE PUMP. ALL KEYS ARE FULLY RESPONSIVE TO USER PRESSES. REMOVED KEYPAD COVER; NO CONTAMINATION WAS FOUND UNDER THE KEY CONTACTS. 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 FOR EVALUATION. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 REPORTING AN INTERMITTENT POWER ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 300MG/DL WITH NAUSEA, VOMITING AND LARGE KETONES. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE ROUTINE CARE OF DIABETES MANAGEMENT. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION EXPERIENCED DUE TO AN ALLEGED INTERMITTENT POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432072 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening