BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4812965 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-61665
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 12, 2015
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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 REPORTED VIA PHONE CALL EXPERIENCING HIGH AND LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT, NO MATTER HOW MUCH INSULIN SHE TOOK, HER BLOOD GLUCOSE WOULD NOT GO DOWN. THE CUSTOMER'S BLOOD GLUCOSE WAS APPROACHING 500 MG/DL. SHE STATED THAT SHE WOKE UP WITH HIGH BLOOD GLUCOSE AND REVERTED TO A DIFFERENT BASAL SETTING ON THE INSULIN PUMP. SHE CHANGED HER INFUSION SET, REWOUND, CONNECTED THE TUBING TO THE RESERVOIR, PUT THE SET IN, PRESSED THE ACT BUTTON, AND STATED THAT THE INSULIN PUMP STOPPED DELIVERING INSULIN BY ABOUT 2 UNITS. SHE FOUND SEVERAL NO DELIVERY ALARMS IN THE DEVICE'S ALARM HISTORY. THE CUSTOMER WAS ADVISED ON HOW TO POTENTIALLY FIX THE PROBLEM IN THE EVENT THAT THE ISSUE RECURRED. SHE WAS ADVISED TO TREAT WITH A MANUAL INJECTION IF NECESSARY TO USE HER BACK-UP PLAN. SHE DECLINED REPLACEMENT OF THE INFUSION SETS AND RESERVOIRS. THE CUSTOMER STATED THAT SHE HAD RECOVERED FROM LOW BLOOD GLUCOSE AND DID NOT REQUIRE ANY FURTHER ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354012 530G INSULIN PUMP OZO OZO MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR