BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3933426 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-87064
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 15, 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
    NV
    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 HIGH BLOOD GLUCOSE LEVELS. CUSTOMER STATED THAT HER SENSOR GLUCOSE VALUES ARE NOT REFLECTING HER BLOOD GLUCOSE READINGS CAUSING THE THRESHOLD SUSPEND ALERT TO GO OFF EVEN WHEN HER BLOOD GLUCOSE READINGS ARE NOT LOW. CUSTOMER MENTIONED RECEIVING NUMEROUS NO DELIVERY ALARMS. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 416 MG/DL AND WILL BE TREATING WITH A MANUAL SHOT. CUSTOMER REPORTED SYMPTOMS OF NAUSEA AND NOT FEELING WELL. TROUBLESHOOTING WAS PERFORMED AND THE DRIVE SUPPORT CAP AND ALL SETTINGS APPEARED TO BE NORMAL. THE HIGH PRESSURE TEST WAS ALSO PERFORMED AND PASSED. THROUGH TROUBLESHOOTING A BENT CANNULA WAS NOTED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409266 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR