BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2183357 · Received July 28, 2011

    Report

    Report Number
    2531779-2011-05442
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/30/2011 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/02/2011 WITH THE FOLLOWING FINDINGS: INVESTIGATORS WERE UNABLE TO COMPLETE TESTING, AS THE PUMP WOULD NOT POWER ON. THERE WAS MOISTURE VISIBLE IN THE DISPLAY SCREEN, AND MOISTURE DAMAGE FOUND ON THE PCB. A DISPLAY LENS LEAK WAS OBSERVED DURING LEAK TESTING.

    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

    IT WAS REPORTED THAT THE REPORTED PUMP REVERTED TO FACTORY DEFAULT DATE/TIME SETTINGS AFTER THE BATTERY WAS REPLACED. THE PATIENT HAS REPLACED THE BATTERY FIVE TIMES. THE PUMP HAD BEEN EXPOSED TO WATER, THERE WERE NO CRACKS IN THE BATTERY CAP, NO CORROSION IN THE BATTERY COMPARTMENT AND THE CAP WAS SECURE AND TIGHT. THE ISSUE WAS NOT RESOLVED. THE PATIENT WAS AWARE OF THE POWER ISSUE AND DID NOT SUFFER ANY ADVERSE EVENT DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR