BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242643 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11713
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/25/2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD IS FULLY INTACT; NO DAMAGE OR PEELING WAS FOUND. THE UP, DOWN AND OK KEYS ARE INTERMITTENTLY RESPONSIVE TO USER PRESSES. THE CONTRAST KEY IS RESPONSIVE TO USER INPUT. THE PUMP PASSED A 29 HOUR FLOW ACCURACY TEST SUCCESSFULLY AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING ACCURATELY. A PINKISH CONTRAST WAS OBSERVED ON THE DISPLAY SCREEN. REMOVED THE PUMP COVER AND INSERTED A NEW TEST SCREEN. THE NEW TEST SCREEN POWERS UP WITH NORMAL CONTRAST AND NO PINK DISCOLORATION. REMOVED THE KEYPAD COVER; CONTAMINATION WAS PRESENT UNDER THE CONTRAST, UP, DOWN AND OK KEY CONTACTS.

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING INTERMITTENT UNRESPONSIVENESS OF THE UP ARROW, DOWN ARROW AND OK BUTTONS BEGINNING ONE MONTH AGO. THE PATIENT HAS REPORTED MISSED A FEW BOLUSES DUE TO THE OK BUTTON NOT RESPONDING WHEN PRESSED. THE PATIENT REPORTEDLY EXPERIENCED HYPERGLYCEMIA OF 400-500 MG/DL WITH NAUSEA AS A RESULT. ELEVATED BLOOD GLUCOSE WAS REPORTEDLY TREATED WITH BOLUS VIA THE PUMP. THE REPORTER DENIED KEYPAD DAMAGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY DUE TO UNRESPONSIVE KEYPAD BUTTONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342849 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR