BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3933260 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-86978
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 STATING THAT HE WENT CAMPING OVER THE WEEKEND AND HIS BLOOD GLUCOSE LEVEL WENT UP. HE WAS ABLE TO LOWER HIS BLOOD GLUCOSE LEVEL. CUSTOMER STATED THE HIGH WAS PROBABLY DUE TO HIM GUESSING AT HIS CARBOHYDRATE INTAKE. HE ALSO REPORTED THAT THE SENSOR READING AND HIS ACTUALLY BLOOD GLUCOSE LEVEL CAN SOMETIMES BE OFF ANYWHERE FROM TWENTY TO EIGHTY POINTS. HIS BLOOD GLUCOSE LEVEL WAS 43 MG/DL, BUT THE SENSOR READ 150 MG/DL. CUSTOMER SAID HE DOES NOT KNOW WHICH ONE TO TRUST SOMETIMES. CUSTOMER USES SITES THAT ARE NOT THE RECOMMENDED SITES. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409758 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR