BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3455588 · Received November 7, 2013

    Report

    Report Number
    2531779-2013-19983
    Event Type
    Malfunction
    Date Received
    November 7, 2013
    Report Date
    October 25, 2013
    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 10/25/2013 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH MOISTURE VISIBLE THRU THE DISPLAY LENS, THE OLED SCREEN IS BLANK DUE TO MOISTURE IN PUMP. THE PUMP BOOTED WITH AUDIO/VIBRATION. THERE WAS MOISTURE CORROSION VISIBLE IN THE BATTERY COMPARTMENT. THE BATTERY COMPARTMENT LEAK WAS FOUND DURING TESTING. THE PUMP COVER WAS REMOVED TO INSPECT INTERNAL COMPONENTS. MOISTURE CORROSION WAS VISIBLE IN PUMP COMPARTMENT. A VISUAL INSPECTION OF BATTERY COMPARTMENT REVEALED, COMPARTMENT CRACK FROM THREADS TO CASE SEAL. THERE WAS A SCRATCHED DISPLAY LENS FOUND AND THE CONTRAST AND OK SYMBOLS WERE WORN. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT IS CRACKED AND THE DISPLAY LENS WAS SCRATCHED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10/25/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577299 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR