BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1981394 · Received December 30, 2010

    Report

    Report Number
    2531779-2010-03231
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Report Date
    December 3, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EVAL OF THE DEVICE CONFIRMED THE ALLEGED ISSUE. THE DOWNLOAD HISTORY INDICATED THAT THE PT PERFORMED A BATTERY CHANGE AFTER A "LOW BATTERY" ALARM OCCURRED ON (B)(6) 2010 AT 21:04. THE BATTERY CHANGE RESULTED WITH THE PUMP RESETTING TO A DEFAULT DATE/TIME OF (B)(6) 2007 AND 12:00 AM. THE PUMP WAS UNABLE TO HOLD THE DATE/TIME AND RESET ITSELF TO THE DEFAULT DATE/TIME. THE PUMP WAS OPENED FOR FURTHER ANALYSIS AND A LEAKING BT1 COMPONENT WAS OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS RESETTING TO THE DEFAULT DATE/TIME ON IT'S OWN WITHOUT BATTERY REMOVAL. THE PT DENIED HAVING ANY BLOOD GLUCOSE EXCURSIONS DUE TO THE ISSUE. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP WAS RESETTING ON IT'S OWN TO THE DEFAULT DATE/TIME. THERE IS NO EVIDENCE; HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PT DID NOT ALLEGE ANY HARM OR INJURY DUE TO THE ALLEGED ISSUE.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1