BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3203248 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-95312
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.PLEASE MEDWATCH REPORT # 3004209178-2013-95311.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE REACHING TO 27.1MMOL/L. IT WAS STATED THAT THE INSULIN PUMP DID NOT ALARM NO DELIVERY, AND THE CUSTOMER'S BLOOD GLUCOSE CONTINUED TO RISE. IT WAS STATED THAT THE CANNULA WAS NOT BENT WHEN IT WAS REMOVED FROM THE BODY. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS NOT PROTRUDED. THE HIGH PRESSURE TEST WAS COMPLETED AND PASSED. THE PROGRAMMING, TIME, AND DATE ON THE DEVICE WERE CORRECT. THE DAILY TOTALS MATCHED WITH THE BOLUS HISTORY, BUT THE BOLUS WIZARD SHOWED 0 UNITS FOR (B)(6), 2013, AND THE CUSTOMER WAS SURE GIVEN SEVERAL BOLUSES FOR THIS DAY. IT WAS MENTIONED THAT THE DEVICE HAS CRACKS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300870 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554CMH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization