BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2190013 · Received August 3, 2011

    Report

    Report Number
    2531779-2011-05591
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DOWNLOAD VERIFIED A BATTERY VOLTAGE DROP ON (B)(6) 2011. THE BATTERY WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. THE BATTERY COMPARTMENT AND CAP WERE FOUND TO BE INTACT. THE PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR 6 HOURS WITHOUT OVERHEATING OR ALARMS. THE PUMP ELECTRICAL CURRENTS WERE TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP COVER WAS REMOVED TO INSPECT FOR INTERNAL MOISTURE AND NONE WAS FOUND. THE POWER FLEX, BATTERY CONNECTIONS AND INTERNAL COMPONENTS WERE TESTED AND NO DEFECTS WERE FOUND. NO PUMP OVERHEATING WAS DUPLICATED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING THAT THE PUMP FELT HOT TO TOUCH. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE REPORTED 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 63 YR