BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4142037 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-32846
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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

    IT WAS REPORTED THAT THE CUSTOMER IS EXPERIENCING DIFFERENCES BETWEEN SENSOR BLOOD GLUCOSE AND BLOOD GLUCOSE. CUSTOMER'S INSULIN PUMP WAS OFF BY 40-60 POINTS. CUSTOMER IS INSERTING SENSOR IN PROPERLY. CUSTOMER MENTIONED INSULIN PUMP RECEIVED A THRESHOLD SUSPEND ALERT, SIX NO DELIVERY ISSUES AND COMMUNICATION ISSUES. EXPERIENCED A WEAK SIGNAL AND LOST SENSOR ALERT. THE BLOOD GLUCOSE READING WAS 120MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621465 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR