BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4153693 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-24909
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    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

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE WAS 492 MG/DL AND HAD BEEN RUNNING HIGH ALL DAY. 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 AND HISTORY WERE CORRECT WITH NO SIGNIFICANT FINDINGS NOTED. THE HIGH PRESSURE TEST WAS PERFORMED AND PASSED. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WAS WORKING AS DESIGNED. SHE WAS FURTHER ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR, AND INSULIN. THE CUSTOMER REMOVED THE INFUSION SET FROM HER BODY AND THE CANNULA WAS NEITHER BENT NOR OCCLUDED. THE SITE WAS NOT SORE OR IRRITATED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631742 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR