BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3854978 · Received June 9, 2014

    Report

    Report Number
    2531779-2014-16123
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 09/05/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE KEYPAD COVER WAS TORN OVER THE UP ARROW BUTTON. EVALUATION REVEALED THAT THE OK KEYPAD BUTTON WAS OVER-RESPONSIVE; THE REPORTED EVENT WAS DUPLICATED. THE KEYPAD COVER WAS REMOVED, AND EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL OF THE KEY CONTACTS. ALSO, ALL OF THE KEY CONTACTS WERE FOUND TO BE INVERTED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THAT MULTIPLE BUTTONS ON THE KEYPAD WERE UNDER RESPONSIVE AND THE KEYPAD WAS DAMAGED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335433 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR