BEUDAMED
    FDA Adverse Event Summary report: N

    530G INSULIN PUMP

    MDR report key: 4240453 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49708
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A HIGH BLOOD GLUCOSE, DESPITE CHANGING OUT THE INFUSION SET. THE CUSTOMER'S BLOOD GLUCOSE WAS 348 MG/DL, AFTER HE HAD HAD A 500 MG/DL BLOOD GLUCOSE AND TREATED WITH A BOLUS. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARED NORMAL. NO AIR BUBBLES WERE FOUND. INSULIN DID EXIT THE TUBING DURING A MANUAL PRIME AND NO LEAKS WERE FOUND. THE SETTINGS WERE CORRECT. THERE WAS A LOW RESERVOIR AND NO DELIVERY ALARM IN THE HISTORY. THE MOST RECENT BOLUS WAS RECORDED. THE CUSTOMER STATED THE CANNULA ON THE PREVIOUS SET WAS NOT BENT OR OCCLUDED. THE INSERTION SITE WAS NOT SORE OR IRRITATED. THE INSULIN WAS WITHIN ITS EXPIRATION DATE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721739 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR