BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4110609 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27442
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 355 MG/DL. THE CUSTOMER REPORTED A NO DELIVERY ALARM FROM THE INSULIN PUMP. THERE WAS PREVIOUS TROUBLESHOOTING DONE ON THE INSULIN PUMP THAT WAS RESOLVED BY RE-PRIMING THE INSULIN PUMP. THE CUSTOMER REPORTED THAT THEY HAVE ALREADY TRIED ALL REMEDIES TO NO AVAIL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589656 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR