BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2182487 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-82206
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 3, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 600 MG/DL. IT WAS STATED THAT THE EVENTS LEADING TO HIS ADMISSION WAS A VIRUS AND POSSIBLE A STOMACH FLU. THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST THREE DAYS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 237 MG/DL AND WAS TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME TEST AND PASSED. PERFORMED A HIGH PRESSURE TEST AND THE TEST FAILED. THE CUSTOMER STATED HAVING BENT CANNULAS IN THE PAST. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE CUSTOMER'S MOTHER CALLED BACK AND STATED THE THAT INSULIN WAS EXPOSED TO A COMPUTED TOMOGRAPHY. 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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization PARADIGM, 6MM CATHETER| UNOMEDICAL INFUSION SET: MMT-399, QUICK-SET, 23,