BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3954790 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21248
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EXAMINED AND FOUND THAT THE BATTERY COMPARTMENT WAS CRACKED BETWEEN THE CASE SEAL AND THE GRIP PAD AND CORROSION WAS OBSERVED INSIDE THE BATTERY COMPARTMENT. DURING TESTING, THE PUMP WAS ABLE TO POWER ON SUCCESSFULLY. THE KEYPAD BUTTONS WERE NOTED TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER ALL OF THE BUTTON CONTACTS. THE PUMP WAS OPENED AND NO FURTHER MOISTURE WAS OBSERVED INSIDE THE PUMP. UNRELATED TO THE BATTERY COMPARTMENT AND KEYPAD ISSUES, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. PRODUCT ANALYSIS EVALUATED THE PUMP AND FOUND THAT THE BATTERY COMPARTMENT WAS CRACKED AND THE KEYPAD BUTTONS WERE INTERMITTENTLY RESPONDING TO BUTTON PRESSES. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433407 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR