BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3930454 · Received July 11, 2014

    Report

    Report Number
    2531779-2014-19809
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Report Date
    July 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/08/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH VISIBLE EVIDENCE OF MOISTURE BEHIND THE DISPLAY LENS AND NO VISIBLE DAMAGE TO THE KEYPAD. DURING TESTING, THE PUMP WAS UNRESPONSIVE DUE TO INTERNAL MOISTURE DAMAGE, AND THE RESPONSIVENESS OF THE KEYPAD BUTTONS WERE UNABLE TO BE CONFIRMED. THE KEYPAD COVER WAS REMOVED AND NO CONTAMINATION WAS FOUND UNDER ANY OF THE KEYPAD BUTTON CONTACTS. THE PUMP CASE WAS CRACKED IN THE RIGHT HAND CORNER OF THE DISPLAY AREA. THE LEAK TEST WAS FAILED DUE TO A CRACK IN THE PUMP CASE. THE PUMP WAS OPENED AND EVIDENCE OF MOISTURE CONTAMINATION WAS OBSERVED INSIDE THE PUMP AND ON THE KEYPAD FLEX CABLE AND CONNECTOR.

    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 THE UP, DOWN, AND OK KEYPAD BUTTONS WERE UNDER-RESPONSIVE. THE REPORTER NOTED THERE WAS EVIDENCE OF MOISTURE BEHIND THE DISPLAY SCREEN LENS. 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
    408103 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR