BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3882513 · Received June 18, 2014

    Report

    Report Number
    2531779-2014-17540
    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
    SC, 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

    FOLLOW-UP #1: DATE OF SUBMISSION 07/30/2014, DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE INITIAL COMPLAINT COULD NOT BE INVESTIGATED DUE TO AN UNRELATED ISSUE. DURING TESTING, THE PUMP POWERED ON WITH FUNCTIONAL AUDITORY AND VIBRATORY SETTINGS, BUT A BLANK DISPLAY DUE TO INTERNAL MOISTURE DAMAGE. THE FUNCTIONALITY OF THE KEYPAD WAS UNABLE TO BE COMPLETED DUE TO THE BLANK DISPLAY. THE PUMP WAS RETURNED WITH NO VISIBLE DAMAGE TO THE KEYPAD. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION WAS FOUND UNDER ANY OF THE KEYPAD BUTTON CONTACTS. THE PUMP COVER WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS OBSERVED INSIDE THE PUMP, ON THE KEYPAD FLEX CABLE AND CONNECTOR. UNRELATED TO THE INITIAL COMPLAINT, THE LEAK TEST WAS PERFORMED AND A CRACK IN THE PUMP CASE WAS OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THE OK, UP, AND DOWN KEYPAD BUTTON WERE UNDER-RESPONSIVE. IT WAS REPORTED THERE WAS EVIDENCE OF MOISTURE INGRESS INTO THE PUMP. 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
    357586 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR