BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3791297 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-84249
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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

    THE CUSTOMER REPORTED HAVING ISSUES WITH THE INSULIN PUMP. HE STATED THAT THE BLOOD GLUCOSE READING WAS DIFFERENT FROM THE SENSOR READING, AND SHE HAD TREATED ACCORDING TO SENSOR, BUT HER GLUCOSE LEVEL WENT UP. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 60MG/D. WHILE SPEAKING TO THE DOCTOR'S NURSE SHE STATED THAT THE CUSTOMER WAS GETTING TOO MUCH INSULIN, AND THE DOCTOR HAS CHANGED HIS BASAL RATES, BUT HE STILL WAS GETTING LOWS. THEN THE CUSTOMER SUSPENDED THE USE OF THE DEVICE AND HIS GLUCOSE LEVEL WAS 404MG/DL. TROUBLESHOOTING WAS NOT PERFORMED AS CUSTOMER BELIEVES THAT THE BASAL RATES NEED TO BE ADJUSTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269154 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR