BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1923634 · Received December 13, 2010

    Report

    Report Number
    2531779-2010-02836
    Event Type
    Injury
    Date Received
    December 13, 2010
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR EVAL AND EVALUATED. THE BATTERY WAS NOT RETURNED WITH THE PUMP. IT WAS VERIFIED THAT THE BATTERY VOLTAGE DROPPED FROM 160 VDC TO 139 VDC ON (B)(6) 2010 FROM 2:20PM TO 8:23PM. THE BATTERY COMPARTMENT AND CAP WERE INTACT AND THERE WAS NO EVIDENCE OF MOISTURE INGRESS. THE PUMP POWERED ON NORMALLY AND THERE WAS NO OVERHEATING OR ALARMS THAT WERE DUPLICATED DURING TESTING. THE POWER FLEX, BATTERY CONNECTIONS AND INTERNAL COMPONENTS WERE TESTED FOR INTERMITTING CONDITIONS, AND NO DEFECTS WERE FOUND. IN CONCLUSION, THE COMPLAINT REGARDING THE PUMP AND BATTERY OVERHEATING COULD NOT BE DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    THE PT CLAIMED THAT THE PUMP IS HOT TO TOUCH OVER THE BATTERY CHAMBER. IT WAS VERIFIED THAT THE PT WAS USING THE PROPER BATTERY (LITHIUM 1.5 V) BATTERY THAT CAME FROM ANIMAS. THE PT STATED THAT THE BATTERY IS LESS THAN 2 WEEKS OLD AND THE PUMP HAS NOT BEEN EXPOSED TO ANY MOISTURE. THE PT DENIED SUFFERING FROM ANY INJURIES AS A RESULT OF THE REPORTED ISSUE. THE PUMP WAS REPLACED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT; HOWEVER, THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED OVERHEATING PUMP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1