BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 5192621 · Received October 30, 2015

    Report

    Report Number
    2032227-2015-61789
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 12, 2015
    Report Date
    October 23, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RETURNED AN EVALUATED BY THE MANUFACTURER ON THE INITIAL REPORT HOWEVER, FAILURE ANALYSIS NOTES WERE NOT PROVIDED ON THE INITIAL REPORT. THE INSULIN PUMP WAS RECEIVED WITH NO BUTTON RESPONSE DUE TO UNLOCKED LCD KEYPAD CONNECTOR. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO NO BUTTON RESPONSE. THE INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHED LCD WINDOW AND SCRATCHED RESERVOIR TUBE WINDOW.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY HAD ISSUES WITH THE KEYPAD ON THEIR INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT THE BUTTONS DO NOT RESPOND. THE CUSTOMER WAS INFORMED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. THE CUSTOMER SENT THE PRODUCT BACK FOR ANALYSIS. A REPLACEMENT PUMP WAS SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722542 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR