BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3873224 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85630
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 DID NOT ALARM NO DELIVERY. CUSTOMER STATED THAT THE BLOOD GLUCOSE READING IS HIGH AND SHE DOES NOT FEEL RIGHT. CUSTOMER HAD A BENT CANNULA AND THE INSULIN PUMP DID NOT ALARM NO DELIVERY. EXPLAINED TO CUSTOMER THAT THE INSULIN PUMP WILL ALARM NO DELIVERY WHEN BACK PRESSURE IS DETECTED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349099 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR