BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3933406 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-87061
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 LOW BLOOD GLUCOSE READINGS AND BELIEVES THAT THE INSULIN PUMP IS OVERCORRECTING AND GIVING TOO MUCH INSULIN. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP AND ALL SETTINGS APPEARED TO BE NORMAL. DISPLACEMENT TEST WAS PERFORMED AND PASSED. THROUGH TROUBLESHOOTING IT WAS ALSO NOTED THAT THE CUSTOMER DID NOT RECEIVE AN ESTIMATE DETAILS MESSAGE DURING THEIR RECENT BOLUS. THE INSULIN PUMP ALSO DID NOT MAKE CORRECT CALCULATIONS BASED ON THE INFORMATION ENTERED. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 391 MG/DL AND HAS TREATED WITH A MANUAL BOLUS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409492 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR