BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2140496 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04473
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Report Date
    May 30, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    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 OK BUTTON WAS FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES AND WAS DIFFICULT TO PRESS. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS OBSERVED UNDER THE BUTTON CONTACTS. UNRELATED TO THE COMPLAINT, THE PUMP FAILED THE IN HOUSE LEAK TEST; THE PUMP WAS FOUND TO BE LEAKING FROM THE DISPLAY SCREEN. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE HAS TO PRESS THE OK BUTTON SEVERAL TIMES IN ORDER TO ACTIVATE A RESPONSE.

    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 20 YR