BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3933092 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86943
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD MISSING SEGMENTS DUE TO CRACKED ZEBRA CONNECTOR ON LCD BOARD. THE INSULIN PUMP HAD A SMALL CRACK ON THE RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING HIS INSULIN PUMP HAS AN INTERMITTENT PARTIAL DISPLAY. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 123 MG/DL. CUSTOMER IS NOW USING AN OLD INSULIN PUMP AS A BACK UP. CUSTOMER USES ENERGIZER BATTERIES. THE DEVICE WAS NOT BUMPED OR DROPPED BEFORE THE ALARM. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE OF IT AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410928 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR