BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2000575 · Received February 1, 2011

    Report

    Report Number
    2531779-2011-00567
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Report Date
    January 2, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY AND THE POWER CIRCUIT DOES NOT DRAW EXCESSIVE CURRENT. THE PUMP WAS EXERCISED WITH NO EVIDENCE OF OVERHEATING. NO DEFECTS WERE FOUND TO THE POWER FLEX, BATTERY CONNECTIONS, AND INTERNAL COMPONENTS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ALLEGING SHORT BATTERY LIFE WITH THE PUMP. HE CLAIMED THAT THE BATTERY THAT CAME WITH THE PUMP ONLY LASTED 2 WEEKS. THE PATIENT HAD RECEIVED THE LOW BATTERY ALARM AND THEN 36 MINUTES LATER, RECEIVED THE REPLACE BATTERY ALARM. WHEN HE CHANGED THE BATTERY, HE FOUND THE PUMP TO BE VERY WARM TO TOUCH AND THE BATTERY WAS TOO HOT TO HOLD IN HER HAND. THE PATIENT DENIED GETTING BURNED OR HAVING ANY INJURIES AS A RESULT OF THE REPORTED ISSUE. THE PATIENT REPLACED THE BATTERY AND THE BATTERY REPORTEDLY LASTED ONLY 24 HOURS AND IT WAS ALSO HOT TO TOUCH. ANIMAS REPLACED THE PUMP. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT; HOWEVER, THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED WARM PUMP AND HOT BATTERY 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

    Patients

    Seq Age Sex Outcome Treatment
    1