BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4022219 · Received August 19, 2014

    Report

    Report Number
    3004209178-2014-95660
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 20, 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 REPORTED RECEIVING A NO DELIVERY ALARM DURING BOLUS ON THE INSULIN PUMP. WHILE ATTEMPTING TO ADMINISTER A FIXED PRIME, THE INSULIN PUMP ALARMED NO DELIVERY AGAIN. BLOOD GLUCOSE LEVEL WAS 290 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499775 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS A2551NASJ

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR