BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4153214 · Received October 8, 2014

    Report

    Report Number
    2531779-2014-28666
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/27/2014 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED BETWEEN THE BUMPER PAD AND THE COVER. THE DISPLAY SCREEN HAD A PINKISH CONTRAST. THE RETURNED BATTERY CAP WAS ABLE TO FULLY ATTACH TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. THE BLACK BOX INDICATED A TIME AND DATE RESET EVENT HAD OCCURRED WITHIN 3 MINUTES OF POWERING THE PUMP OFF. THE PUMP WAS EXERCISED FOR 24 HOURS; THE BATTERY WAS THEN REMOVED FOR 6 HOURS AND THEN REINSERTED. THE TIME AND DATE WAS OBSERVED TO HAVE RESET TO 12:00AM (B)(4) 2007, WHICH INDICATED THAT AN INTERNAL CLOCK BATTERY MALFUNCTION HAD OCCURRED, AND WAS CONFIRMED BY A VISIBLE INSPECTION WHEN THE COVER WAS REMOVED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT AND A PINK DISPLAY SCREEN. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/27/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630753 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR