BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3833502 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-85024
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 STATED THAT HIS INSULIN PUMP IS NOT DELIVERING THE BOLUS. THE BLOOD GLUCOSE READING WAS 138 MG/DL. THE CUSTOMER STATED THAT HE BELIEVES THE BASAL RATE INSULIN IS NOT BEING DELIVERED. DURING TROUBLESHOOTING, THE CUSTOMER NOTICED LOW RESERVOIR ALARM AND IN THE INSULIN PUMP HISTORY, DURING SOME OF THE BOLUSES THE BLOOD GLUCOSE READINGS WERE NOT RECORDED. ALSO, THE CUSTOMER WAS ASKED TO PERFORM THE DISPLACEMENT TEST AND THE TEST PASSED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310356 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR