BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3791178 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-84335
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 INSULIN PUMP IS OVER-DELIVERING INSULIN. THE CURRENT BLOOD GLUCOSE READING IS 198 MG/DL. CUSTOMER IS NOT FEELING WELL. CUSTOMER WAKES UP WITH HIGHS. CUSTOMER HAS TREATED WITH THE INSULIN PUMP. DURING TROUBLESHOOTING, TIME AND DATE ARE CORRECT. THE BOLUS WIZARD SETTINGS ARE INCORRECT. ASSISTED WITH CORRECTING. HIGH PRESSURE TEST PASSED. CUSTOMER ALSO STATED THAT SHE ENTERED 45 CARBOHYDRATE AND THE INSULIN PUMP DELIVERED 6.2 UNITS SENDING THE BLOOD GLUCOSE LEVEL TO 52 MG/DL. CUSTOMER HAS ALSO WENT FROM 196 MG/DL TO 335 MG/DL AFTER BOLUSING. CUSTOMER STATED THAT THE INSULIN PUMP IS NOT GIVING HER THE CORRECT BOLUS AMOUNTS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268926 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR