BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4132030 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-30952
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP DISPLAY SCREEN WAS BLANK AND THE DEVICE WAS ALARMING. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED IF THE DEVICE SHOWED PHYSICAL DAMAGE AND CUSTOMER STATED IT DOES NOT. NEXT, CUSTOMER WAS ASKED IF THE BATTERY COMPARTMENT APPEARED DAMAGED. CUSTOMER STATED IT DOES NOT. AFTERWARDS, CUSTOMER WAS ADVISED TO CLEAN BATTERY CAP WITH COTTON SWAB AND REINSERT BATTERIES. CUSTOMER STATED THEY DID NOT HAVE NEW BATTERIES AVAILABLE AND WOULD CALL BACK TO CONTINUE TROUBLESHOOTING. ADVISED CUSTOMER TO CHANGE ENTIRE SET AND MONITOR DEVICE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611235 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR