BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1973017 · Received January 20, 2011

    Report

    Report Number
    2531779-2011-00383
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Report Date
    December 22, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS FOR INVESTIGATION. EVAL REVEALED THE FOLLOWING: THE BATTERY WAS NOT RETURNED WITH THE PUMP, THE BLACK BOX DOWNLOAD CONFIRMED A BATTERY VOLTAGE DROP FROM 163 VDC AT 19:13 ON (B)(6) 2010 TO 128 VDC AT 4:06 AM ON (B)(6) 2010, THE BATTERY COMPARTMENT APPEARED TO BE INTACT, NO EVIDENCE OF MOISTURE INGRESS, THE PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR 9 HRS WITH NO OVERHEATING OR ALARMS, THE PUMP ELECTRICAL CURRENT TESTS WERE WITHIN SPECIFICATIONS, NO DEFECTS WERE FOUND WITH THE POWER FLEX, AND BATTERY CONNECTIONS AND INTERNAL COMPONENTS. IN CONCLUSION, THE ALLEGED ISSUE COULD NOT BE DUPLICATED DURING INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DISPLAYED THE LOW BATTERY MESSAGE AND THAT THE PUMP WAS HOT. THE PT STARTED USING THE PUMP 5 DAYS AGO AND WAS USING THE ULTIMATE LITHIUM BATTERY THAT CAME UP WITH THE PUMP. THE RPTR DENIED ANY SIGNS OF CORROSION OR ANYTHING ABNORMAL IN THE BATTERY COMPARTMENT. THERE WERE NO REPORTED INJURIES AS A RESULT OF THE HOT PUMP. THE LITHIUM BATTERY WAS REPLACED WITH AN ALKALINE BATTERY: THE PT'S MOM STATED THAT THE PUMP APPEARS TO BE FUNCTIONING FINE. 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 CORPORATION ONE TOUCH PING

    Patients

    Seq Age Sex Outcome Treatment
    1