BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3942969 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87672
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 WAKING UP WITH HIGH BLOOD SUGAR LEVELS BETWEEN 300 MG/DL TO 400 MG/DL. CUSTOMER STATED THAT HER DOCTOR SUGGESTED THAT THE HIGH BLOOD SUGAR LEVELS MAY BE DUE TO HER HORMONES. CUSTOMER DOES NOT BELIEVE THE ISSUE IS WITH THE INSULIN PUMP. CUSTOMER REPORTED TROUBLE WITH FILLING HER INSULIN AND STATED THAT SHE ONLY GETS SEVEN VIALS AND THEY ARE NOT LASTING HER. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419510 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR