BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2123171 · Received June 10, 2011

    Report

    Report Number
    3004209178-2011-81730
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPOGLYCEMIA, WITH BLOOD GLUCOSE OF 25 MG/DL. THE CUSTOMER'S DOCTOR STATED THAT THE CUSTOMER WAS DRIVING AND BLACKED OUT AT THE WHEEL, WHICH LED TO AN ACCIDENT. THE CUSTOMER'S DOCTOR THEN STATED THAT HE BELIEVES THE CUSTOMER'S LOW BLOOD GLUCOSE CAUSED THE BLACK OUT. THE CUSTOMER'S DOCTOR ALSO STATED THAT THE CUSTOMER DOES NOT HAVE ANY INJURIES. IT WAS FOUND THAT THE INSULIN PUMP HAD GIVEN A LOW ALARM BUT THAT THE CUSTOMER HAD NOT HEARD THE ALARM. THE CUSTOMER STATED THAT SHE LAST CHANGED THE INFUSION SET THE DAY BEFORE THE EVENT. PROGRAMMING WAS CORRECT AND TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE SELF TEST. NOTHING FURTHER WAS REPORTED.

    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-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization