BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173775 · Received July 24, 2011

    Report

    Report Number
    2531779-2011-05175
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 19, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. UPON EXAMINATION CORROSION ON THE BATTERY CAP WAS NOTED. THE BATTERY COMPARTMENT WAS INTACT WITH NO PHYSICAL DAMAGE OR EVIDENCE OF MOISTURE OBSERVED. UNRELATED TO THE COMPLAINT, THE AUDIO BOLUS BUTTON WAS ABSENT. THE PUMP USER GUIDE INSTRUCTS THE USER TO INSPECT THE PUMP AND CONFIRM THAT IT IS OPERATING PROPERLY. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. EVALUATION FOUND THAT PUMP POWERS UP PROPERLY AND THE POWER CIRCUIT DOES NOT DRAW EXCESSIVE CURRENT. THE PUMP WAS EXERCISED FOR 7 HOURS WITH NO EVIDENCE OF OVERHEATING OR POWER ISSUES. NO INTERMITTENT DEFECTS WERE FOUND WHEN THE POWER FLEX, BATTERY CONNECTIONS, AND INTERNAL COMPONENTS WERE TESTED. THE PUMP COVER WAS REMOVED AND NO EVIDENCE OF INTERNAL MOISTURE INGRESS WAS OBSERVED. THE COMPLAINT OF HEAT COULD NOT BE VERIFIED OR DUPLICATE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT ON (B)(6) 2011 THE PUMP WOKE HER UP WITH A REPLACE BATTERY ALARM; THE PUMP WAS VERY HOT WHEN SHE TOUCHED IT TO CONFIRM THE ALARM. SHE ALLEGED THAT SHE THE PUMP WAS TOO HOT TO HOLD SO SHE USED POT HOLDERS TO REMOVE THE BATTERY WHICH WAS ALSO HOT; THE BATTERY WAS CORRODED. THE PATIENT NOTED THAT THERE WERE MILD BROWN SPOTS INSIDE THE BATTERY COMPARTMENT. SHE REPORTED THAT SHE WAS USING A LITHIUM BATTERY THAT WAS SHIPPED WITH THE PUMP IN (B)(6) 2010. IT IS NOTEWORTHY THAT SHE SAID SHE DID NOT START PUMP USE UNTIL (B)(6) 2011; SHE DID NOT SAY HOW THE PUMP WAS STORED DURING THAT TIME PERIOD. SHE STATED THAT THERE WERE NO CRACKS IN OR NEAR THE BATTERY COMPARTMENT, THE DISPLAY SCREEN IS NOT VISIBLE, AND THE AUDIO BUTTON IS NOW MISSING BUT THAT ISSUE OCCURRED AFTER THE HOT PUMP EPISODE. THIS COMPLAINT IS BEING REPORTED BECAUSE THERE IS THE POSSIBILITY THAT AN OVERHEATED PUMP MIGHT CAUSE AN INJURY IF IT WERE TO RECUR. THERE IS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR