BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2072685 · Received April 29, 2011

    Report

    Report Number
    2531779-2011-02988
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 [DATE OF SUBMISSION (B)(6) 2011] - DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011, WITH THE FOLLOWING FINDINGS: THE BATTERY WAS RETURNED WITH THE PUMP AND SHOWED NO EVIDENCE OF OVERHEATING. THE BATTERY COMPARTMENT AND CAP ARE INTACT WITH NO PHYSICAL DAMAGE OR EVIDENCE OF MOISTURE INGRESS OBSERVED. THE PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR 5 HOURS, NO OVERHEATING OR ALARMS WERE DUPLICATED. THE PUMP'S ELECTRICAL CURRENT DRAWS WERE TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE POWER FLEX, BATTERY CONNECTIONS AND INTERNAL COMPONENTS WERE TESTED FOR INTERMITTING CONDITIONS, NO DEFECTS WERE FOUND. COMPLAINT REGARDING PUMP AND BATTERY OVERHEATING COULD NOT BE DUPLICATED DURING INVESTIGATION. NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THE REPORT IS UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER CONTACTED ANIMAS (B)(4) TO REPORT THAT THE PUMP WAS HOT TO THE TOUCH AFTER RECEIVING A LOW BATTERY WARNING. THE REPORTER DENIED ANY BODILY HARM TO THE PATIENT AS A RESULT OF THE ISSUE. AT THE TIME OF TROUBLESHOOTING, THE PATIENT'S MOTHER CONFIRMED THAT THE PUMP WAS NOT EXPOSED TO MOISTURE OR CLEANED WITH ANYTHING. AT THE TIME OF THE CALL, THE BATTERY WAS REMOVED FROM THE PUMP AND THE REPORTER CONFIRMED THERE WAS NO MOISTURE OR CORROSION FOUND INSIDE THE BATTERY COMPARTMENT, BATTERY CAP, OR BATTERY. IT WAS NOTED THAT THE PUMP STILL HAD THE ORIGINAL ENERGIZER LITHIUM BATTERY THAT IT CAME WITH. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED.

    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