BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3230409 · Received July 16, 2013

    Report

    Report Number
    2531779-2013-11046
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    July 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 09/09/2013 WITH THE FOLLOWING FINDINGS: THE COMPLAINT OF THE DIM DISPLAY SCREEN WAS NOT ABLE TO BE DUPLICATED; THE PUMP POWERED ON AND THE DISPLAY WAS CLEAR AND LEGIBLE. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE KEYPAD COVER WAS TORN OVER THE OK BUTTON. DURING TESTING, ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY TO BUTTON PRESSES. THE KEYPAD WAS REMOVED AND NO DAMAGE OR CONTAMINATION WAS FOUND UNDER THE KEY CONTACTS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DIM DISPLAY ISSUE. THE SCREEN HAS BEEN GRADUALLY FADING OVER TIME AND AT THE TIME OF THE COMPLAINT IS DIFFICULT TO VIEW. 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
    329049 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR