BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4241202 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50023
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    August 19, 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
    CO
    Reporter Occupation
    PATIENT

    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

    CUSTOMER REPORTED THAT HE EXPERIENCED LOW BLOOD GLUCOSE AND THE PARAMEDICS WERE CALLED. CUSTOMER STATED HE WAS SLEEPING AND REGAINED CONSCIOUSNESS IN THE MORNING. BLOOD GLUCOSE VALUE WAS 31 MG/DL. CUSTOMER DID NOT GO TO THE HOSPITAL. CUSTOMER STATED THAT HE KNOWS THE CAUSE OF THE HYPOGLYCEMIC EVENT WAS NOT DUE TO THE INSULIN PUMP BECAUSE THE INFUSION SET HAD COME OUT AT NIGHT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723804 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention