BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4090452 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23133
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE READINGS. IT WAS NOTED THAT THE CUSTOMER KEPT THE SAME INFUSION SET ON AND ONLY CHANGED OUT THE RESERVOIR. FILLING THE TUBING THAT WAS PREVIOUSLY FILLED CAUSED THE CUSTOMER'S BLOOD GLUCOSE READINGS TO DROP TO 20 MG/DL. CUSTOMER ALSO EXPERIENCED A LOW THE NIGHT BEFORE AND THE BLOOD GLUCOSE READINGS WERE 36 MG/DL. CUSTOMER STATED THAT THIS LOW MAY HAVE BEEN CAUSED BY OVER COMPENSATION AS THEY WERE BOLUSING FOR A MEAL AND A HIGH BLOOD GLUCOSE READING. CUSTOMER DECLINED ANY FURTHER ASSISTANCE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570281 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization