BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3933126 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86956
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 13, 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
    GA
    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

    IT WAS REPORTED BY THE CUSTOMER THAT THEY HAD A BLOOD GLUCOSE LEVEL OF 459 MG/DL AND TREATED WITH MANUAL INSULIN INJECTIONS. CUSTOMER STATED THEY HAD BREAKFAST AND ADMINISTERED BOLUS WITH A BLOOD GLUCOSE LEVEL ABOVE 300MG/DL. CUSTOMER ALSO HAD LUNCH AND ONCE AGAIN BOLUSED, WHICH CAUSE CUSTOMER'S BLOOD GLUCOSE LEVELS TO RISE ABOVE 400 MG/DL. ADVISED CUSTOMER TO DISCONNECT FROM DEVICE. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO CHECK THE CONDITION OF THE DRIVE SUPPORT CAP ON THE DEVICE AND FOUND IT TO BE NORMAL. NEXT, CUSTOMER WAS ASKED TO CHECK FOR AIR BUBBLES IN INFUSION SET TUBING. CUSTOMER VERIFIED THERE WERE NO AIR BUBBLES. AFTERWARDS, RESERVOIR WAS REINSERTED INTO INSULIN PUMP AND A MANUAL PRIME WAS PERFORMED. DEVICE PASSED PRIMING, HIGH PRESSURE TEST AND INSULIN EXITED TUBING. CUSTOMER VERIFIED DEVICE WAS NOT LEAKING AND DID NOT ALARM. ADVISED TO CHANGE ENTIRE SET, RESERVOIR AND INSULIN. CUSTOMER'S BLOOD GLUCOSE LEVEL 459 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409927 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR