BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3982229 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90149
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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

    CUSTOMER CALLED REPORTING HIGH BLOOD GLUCOSE LEVELS WHEN WEARING HIS INSULIN PUMP. LAST NIGHT, CUSTOMER'S BLOOD GLUCOSE WAS 45 MG/DL. HE DRANK OJ AND ATE COTTAGE CHEESE, AN ICE CREAM BAR, AND SOME NUTS, AND TOOK THREE GLUCOSE TABLETS. HIS BLOOD GLUCOSE ROSE TO 90 MG/DL, BUT WHEN HE WOKE UP THE NEXT DAY IT WAS AT 583 MG/DL. HE TREATED WITH A TWENTY UNIT BOLUS FROM THE DEVICE. HE EXPERIENCED THIRST, DRY MOUTH, AND NOT FEELING WELL. BY THE END OF THE CALL, CUSTOMER'S BLOOD GLUCOSE WAS 380 MG/DL. THE DRIVE SUPPORT CAP APPEARS NORMAL. THERE WAS NO AIR IN THE INFUSION SET. INSULIN EXITED DURING A MANUAL PRIME. THE ALARM HISTORY SHOWS SEVERAL THRESHOLD SUSPEND ALARMS. THE DEVICE PASSED THE HIGH PRESSURE TEST. CUSTOMER ALSO MENTIONED ISSUES WITH HIS SENSORS, BUT DECLINED TROUBLESHOOTING TO FOCUS ON THE INSULIN PUMP. HE WAS ADVISED TO MONITOR THE DEVICE AND CALL WHEN THERE ARE PROBLEMS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457379 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention