BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3970002 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88391
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 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

    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 INSULIN PUMP ALARMED NO DELIVERY DURING BOLUS PROCEDURE. THE BLOOD GLUCOSE READING WAS 398 MG/DL AROUND ONE HOUR AFTER AN INFUSION SET CHANGE. THE CUSTOMER STATED THAT HIS WHOLE BOLUS MAY NOT HAVE BEEN DELIVERED. HE TREATED WITH THE INSULIN PUMP AND REPORTED THAT HE FELT GOOD. A BENT INFUSION SET CANNULA WAS OBSERVED, AND THE ISSUE WAS RESOLVED BY A COMPLETE INFUSION SET CHANGE. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT BECAUSE EVERYTHING WORKED CORRECTLY AFTER THE SET CHANGE. HE DECLINED TO RETURN THE INFUSION SET AND RESERVOIR FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446570 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR UNOMEDICAL PRODUCT