BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4241126 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49740
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT HE TOOK BOLUS; HIS BLOOD GLUCOSE WAS 300 MG/DL AND CURRENTLY 430 MG/DL. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 430 MG/DL. CUSTOMER STATED TREATED HIGH BLOOD GLUCOSE. CUSTOMER STATED HE DOES NOT HAVE EXTRA INFUSION SET. CUSTOMER STATED THAT HIS BLOOD GLUCOSE NOW WAS 340 MG/DL. CUSTOMER HUNG UP BEFORE THE CALL COULD CONTINUE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723680 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR