BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4252133 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52739
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 18, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS NOT ABLE TO OVER-RIDE THE ACTIVE INSULIN FUNCTION ON THE PUMP SO THAT THE PUMP WOULD DELIVER THE ORIGINAL CALCULATED DOSE IN INSTANCES WHERE A PREVIOUS NO DELIVERY CAUSED THAT INFORMATION TO BE INVALID. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 348 MG/DL. IT WAS EXPLAINED THAT THE BOLUS WIZARD DOES PROVIDE A REVIEW OF THE MATH BEFORE THEY CAN DELIVER THE INSULIN AND THEY CAN THEN MANUALLY ADD BACK IN THE INSULIN PER HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. CUSTOMER WAS REFERRED TO THEIR HEALTH CARE PROFESSIONAL FOR FURTHER INSTRUCTIONS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737767 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR