BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3191313 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09054
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION AND EVALUATED ON (B)(4) 2013. THE KEYPAD APPEARED TO BE INTACT; HOWEVER, THE CONTRAST KEYPAD BUTTON WAS INTERMITTENTLY RESPONDING TO USER INPUTS AND THERE WAS EVIDENCE OF CONTAMINATION UNDER THE KEY CONTACTS. DURING THE EVALUATION, TWO SECONDARY ISSUES WERE DISCOVERED, UNRELATED TO THE KEYPAD COMPLAINT. THE BATTERY COMPARTMENT WAS CRACKED AND THE BT1 INTERNAL BATTERY WAS FOUND TO BE LEAKING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS TO REPORT THE DOWN ARROW KEYPAD BUTTON HAD TO BE PRESSED MULTIPLE TIMES IN ORDER TO ACTIVATE THE DESIRED PUMP FUNCTIONS. THE PATIENT NOTED THERE HAD BEEN NO TRAUMA TO THE PUMP, NO MOISTURE EXPOSURE AND NO POWER LOSS. THE ISSUE WAS NOT RESOLVED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289809 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR