BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2842820 · Received November 21, 2012

    Report

    Report Number
    2531779-2012-13863
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    November 2, 2012
    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)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE BATTERY WAS NOT RETURNED WITH THE PUMP. THE BATTERY COMPARTMENT AND CAPS ARE INTACT WITH NO DAMAGE OR MOISTURE INGRESS. PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR THREE HOURS NO OVERHEATING WAS DUPLICATED. PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP COVER WAS REMOVED TO INSPECT FOR INTERNAL MOISTURE INGRESS, NONE WAS FOUND. POWER FLEX AND POWER CIRCUIT WERE TESTED FOR INTERMITTING CONDITIONS, NO DEFECTS WERE FOUND. THERE WAS NO DEFECT FOUND.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THEY NOTICED THAT THEIR PUMP WAS HOT TO TOUCH. THE PATIENT CONFIRMED THAT THERE WAS NO TRAUMA TO THE PUMP. THE PATIENT STATED THERE WAS NO MOISTURE OR CORROSION NOTED IN THE BATTERY COMPARTMENT. THE PATIENT REPORTED THAT THEY REMOVED BATTERY AND THE BATTERY WAS MUCH HOTTER THAN THE PUMP. THE PATIENT STATED THAT THEY THREW AWAY THE THE BATTERY AND REPLACED IT AND THE PUMP WENT BACK TO NORMAL TEMPERATURE. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE HOT PUMP ISSUE.

    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 53 YR