BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1942265 · Received December 22, 2010

    Report

    Report Number
    2531779-2010-03037
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT THE PUMP FELT WARM AND THE BATTERY LIFE LASTED ONLY 1-2 WEEKS. THE REPORTER CHECKED THE BATTERY CAP AND IT WAS SECURE AND THERE WAS NO MOISTURE/CORROSION IN THE BATTERY COMPARTMENT. ACCORDING TO THE ALARM HISTORY, THE PUMP HAD A LOW BATTERY MESSAGE ON (B)(6) 2010 AND (B)(6) 2010 AND A REPLACE BATTERY MESSAGE ON (B)(6) 2010. THERE WAS NO REPORTED PT IMPACT WITH THE ALLEGED ISSUE. THE PUMP WAS REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1