BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2033791 · Received March 23, 2011

    Report

    Report Number
    2531779-2011-01812
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE PUMP REBOOTED WITHOUT USER INTERVENTION. SHE SAID THAT SHE REPLACED THE BATTERY AFTER RECEIPT OF A LOW BATTERY ALARM WITH A LITHIUM 1.5 VOLT NON RECHARGEABLE ULTIMATE BATTERY. THE PT NOTED THAT SHE COMPLETED FULL REWIND, LOAD CARTRIDGE, AND PRIME STEPS AT THAT TIME. SHE SAID THAT SHE WENT TO BED AND HOURS LATER AWAKENED WITH A DISPLAY SCREEN MESSAGE REQUEST TO VERIFY BATTERY TYPE AND CONFIRM THE TIME/DATE. THE PT REPORTED THAT THE BATTERY AND CARTRIDGE CAPS WERE SECURE AND THERE WAS NO YELLOW O-RING VISIBLE. SHE INSPECTED THE CAPS AND PUMP; SHE DENIED AY VISIBLE STRUCTURAL DAMAGE OR DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR