BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3881412 · Received June 18, 2014

    Report

    Report Number
    2531779-2014-17468
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    June 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS PEELED OFF THE PUMP. THE OK AND UP ARROW BUTTONS HAD AN INTERMITTENT RESPONSE AND THE CONTACTS WERE FOUND TO BE INVERTED. CONTAMINATION WAS FOUND UNDER THE UP ARROW BUTTON CONTACT. UNRELATED TO THE ORIGINAL COMPLAINT, THERE WAS A CRACK ALONG THE BATTERY COMPARTMENT THREADS. ALSO UNRELATED, THE PUMP BOOTED TO THE VERIFY SCREEN WITH A DIM AND DISCOLORED CONTRAST.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (DAMAGE PRIOR TO TACTILE CHANGE) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357704 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR