BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4860747 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-67783
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY AND SHUT OFF UNEXPECTEDLY. THE CUSTOMER STATED THAT HE DID NOT REALIZE UNTIL HIS BLOOD GLUCOSE WENT HIGH. HE REPORTED THAT HE ATTEMPTED TO THE RESOLVE THE ISSUE WITH 4 DIFFERENT BATTERIES, BUT THE DISPLAY STILL TURNED OFF WITHOUT WARNING. THE CUSTOMER'S BLOOD GLUCOSE WAS 190 MG/DL. HE DID NOT OBSERVE ANY DAMAGE OR CORROSION TO THE BATTERY CAP, BATTERY COMPARTMENT AND SPRING. HE STATED THAT THE INSULIN PUMP DID NOT SHOW ANY SIGNS OF PHYSICAL DAMAGE, HAD NOT BEEN DROPPED OR BUMPED, AND HAD NOT BEEN EXPOSED TO MOISTURE. HE DID NOT HAVE NEW BATTERIES WITH WHICH TO TEST THE INSULIN PUMP AND WAS ADVISED THAT A REPLACEMENT BATTERY CAP WOULD BE SENT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN UNTIL THE REPLACEMENT BATTERY CAP ARRIVED. HE NOTED THAT WHEN HE TAPPED THE SIDE OF THE DEVICE, THE DISPLAY CAME BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402676 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR