BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4230721 · Received November 6, 2014

    Report

    Report Number
    2531779-2014-31717
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/15/2014 WITH THE FOLLOWING FINDINGS: THE DISPLAY WAS OBSERVED TO BE DIM, FADING, AND REDDISH IN COLOR. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED BELOW THE BUMPER PAD. THE BLACK BOX SHOWED A TIME AND DATE RESET TO THE DEFAULT SETTING AFTER A BATTERY CHANGE ON (B)(6) 2014. THE PUMP WAS EXERCISE FOR 24 HOURS. THE BATTERY WAS THEN REMOVED FOR 6 HOURS AND A TIME AND DATE RESET OCCURRED WHEN THE BATTERY WAS REINSERTED. THE PUMP CASE WAS REMOVED FOR FURTHER INVESTIGATION AND CORROSION WAS FOUND UNDERNEATH THE INTERNAL CLOCK BATTERY COMPONENT. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM, FADING, REDDISH COLORED DISPLAY, A CRACKED BATTERY COMPARTMENT AND CORROSION UNDER THE INTERNAL CLOCK BATTERY COMPONENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10/15/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715525 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR