BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2823561 · Received November 8, 2012

    Report

    Report Number
    2531779-2012-13260
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Report Date
    October 15, 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

    (B)(4):THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT THE DOWN ARROW KEYPAD BUTTON WAS STICKING, INTERMITTENTLY RESPONSIVE AND REQUIRED EXCESSIVE FORCE TO ELICIT A RESPONSE. THE DOWN ARROW KEYPAD BUTTON WAS ALSO FOUND TO BE HYPERSENSITIVE CAUSING SCROLLING. ALL OTHER KEYPAD BUTTONS WERE RESPONDED TO BUTTON PRESSES AS EXPECTED. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER THE KEY CONTACTS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 THE DOWN ARROW BUTTON WAS NOT ALWAYS RESPONDING WHEN PRESSED AND HAD INTERMITTENT RESPONSE FOR A FEW DAYS. THE PATIENT STATED THAT THERE WAS NO NOTED DAMAGE TO THE KEYPAD AND NO SIGNS OF MOISTURE IN THE PUMP. THE PATIENT REPORTEDLY WORE THE PUMP IN A LEATHER CASE ATTACHED AT THE WAIST AND CLEANED THE PUMP WITH A DRY CLOTH. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE KEYPAD RESPONSE 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 50 YR