BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4090937 · Received September 15, 2014

    Report

    Report Number
    2531779-2014-26315
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    September 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/30/2014 WITH THE FOLLOWING FINDINGS:MOISTURE EVIDENT BEHIND DISPLAY LENS. DUE TO INTERNAL MOISTURE CONTAMINATION PUMP POWERS WITH THE RETURNED BATTERY CAP TO A AUDIBLE TONE, NO VIBRATION AND A MULTI COLORED DISTORTED DISPLAY IMAGE. BATTERY CAP IS ABLE TO FULLY TIGHTEN. BATTERY COMPARTMENT INTACT. A POWER LOSS WAS NOT DUPLICATED. DUE TO INTERNAL MOISTURE CONTAMINATION KEYPAD IS UNRESPONSIVE. KEYPAD IS INTACT, NO PEELING. REMOVED KEYPAD. NO CONTAMINATION UNDER KEY CONTACTS.. UNABLE TO COMPLETE ALL TESTING STEPS DUE TO INTERNAL MOISTURE DAMAGE/UNRESPONSIVE KEYPAD. PUMP CASE CRACKED IN CORNER OF DISPLAY AREA. LEAK TEST SHOWS LEAK AT CRACK IN PUMP CASE. PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION SEEN THROUGHOUT INSIDE OF PUMP, ON KEYPAD FLEX CABLE AND CONNECTOR AND ASSOCIATED OTHER ELECTRICAL COMPONENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. 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
    568472 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR