BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3935828 · Received July 15, 2014

    Report

    Report Number
    2032227-2014-03860
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    CUSTOMER REPORTED THAT SHE HAS BEEN HAVING ISSUES WITH LOW BLOOD GLUCOSE LEVELS IN THE MORNING. AT 7:00 AM BLOOD GLUCOSE LEVEL IS 70 MG/DL TREATED BY DRINKING A GLASS OF JUICE. AT 7:30 AM BLOOD GLUCOSE LEVEL LOWERED TO 48 MG/DL, SO SHE SUSPENDED THE INSULIN PUMP AND DRANK ANOTHER GLASS OF JUICE. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. DRIVE SUPPORT CAP IS NORMAL. CUSTOMER CHANGES INFUSION SET EVERYDAY. REVIEWED PRIMING TECHNIQUE. CUSTOMER STATED SETTINGS ARE CORRECT. HAD A 7:30 AM BASAL THAT STARTED THAT DAY AND IT WAS SUSPENDED. WAS UNABLE TO PERFORM DISPLACEMENT TEST. CUSTOMER WAS ADVISED TO SPEAK TO HER DOCTOR. CUSTOMER STATED THE DEVICE WAS EXPOSED TO X-RAY. CUSTOMER INSURED THAT SHE DOES NOT USE BOLUS WIZARD AND ONLY USES MANUAL BOLUS IN BLOOD GLUCOSE IS 200 MG/DL AT BREAKFAST. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414026 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR