BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2234113 · Received August 30, 2011

    Report

    Report Number
    3004209178-2011-82772
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    August 14, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS OVER 400MG/DL. THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST FOUR DAYS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 146MG/DL, AND SHE HAS TREATED WITH THE INSULIN PUMP AND MANUAL INJECTIONS. REVIEWED THE PROGRAMMING AND FOUND THAT THE DAILY TOTALS DO NOT MATCH TO THE INSULIN DELIVERY. THE DAILY TOTALS SHOWED 29.35 UNITS WHEN IT WAS DELIVERED 42.05 UNITS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization QUICK-SET, 23:| PARADIGM, 9MM CATHETER:| UNOMEDICAL INFUSION SET: (B)(4)