BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3983363 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22547
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE REPORTED KEYPAD RESPONSIVENESS ISSUE COULD NOT BE ADEQUATELY INVESTIGATED DUE TO AN UNRELATED DIM DISPLAY ISSUE, WHICH WAS DOCUMENTED UNDER (B)(4); NO CONCLUSIONS CAN BE DETERMINED IN REGARD TO THE KEYPAD RESPONSIVENESS ISSUE. VISUAL INSPECTION REVEALED THAT THE KEYPAD COVER WAS INTACT AND FREE OF DAMAGE. THE KEYPAD COVER WAS REMOVED, AND EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL OF THE KEY CONTACTS. A CARTRIDGE CAP AND BATTERY CAP WERE NOT RETURNED WITH THE PUMP; A TEST CARTRIDGE CAP AND TEST BATTERY CAP WERE USED DURING THE ANALYSIS. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/ UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THAT ALL OF THE KEYPAD BUTTONS WERE UNDER RESPONSIVE. 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
    460314 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR