BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3071320 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04780
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP DISPLAY SCREEN WAS FOUND TO BE FADED AND DISCOLORED MAKING THE SCREEN DIFFICULT TO READ. THE DISPLAY SCREEN WAS REPLACED WITH A TEST SCREEN AND THE DISPLAY RETURNED TO NORMAL. UNRELATED TO THE DISPLAY ISSUE, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE PUMP BLACK BOX HISTORY REVEALED MULTIPLE UNEXPLAINED POWER EVENTS. DURING TESTING, A TEST BATTERY CAP WAS ABLE TO SECURE TO THE PUMP AND THE PUMP WAS ABLE TO EXERCISE FOR 24 HOURS WITHOUT POWER EVENTS OCCURRING. ALSO UNRELATED TO THE DISPLAY ISSUE, THE PUMP VIBRATORY ALARM WAS NOT RESPONDING; THE VIBRATION MOTOR WAS FOUND TO BE MISALIGNED ON THE PINS. ALSO UNRELATED TO THE DISPLAY ISSUE, 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. 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)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. PRODUCT ANALYSIS EVALUATED THE PUMP AND FOUND A FADED AND DISCOLORED DISPLAY SCREEN. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172011 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR