BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4073255 · Received September 9, 2014

    Report

    Report Number
    2032227-2014-18335
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A HIGH BLOOD GLUCOSE READING OF OVER 600 MG/DL, WHICH THE CUSTOMER TREATED WITH A MANUAL INJECTION. THE CUSTOMER STATED THAT SHE WAS NOT ABLE TO REWIND THE INSULIN PUMP. SHE NOTED THAT SHE HAD TAKEN A SHOWER WITH THE DEVICE ON, ALTHOUGH NO MOISTURE WAS CURRENTLY VISIBLE IN THE INSULIN PUMP. THERE WERE NO ALARMS IN THE DEVICE ALARM HISTORY THAT INDICATED THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE DEVICE PASSED THE SELF TEST DURING TROUBLESHOOT. ASSISTED THE CUSTOMER WITH REWINDING THE INSULIN PUMP AND FOUND THAT IT WAS WORKING PROPERLY. ADVISED TO MONITOR THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554773 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR