BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2171117 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-82120
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 DUE TO HIGH BLOOD GLUCOSE OVER 600 MG/DL. IT WAS STATED THAT THE EVENTS LEADING TO HER ADMISSION WAS THIRSTY AND HER BLOOD WAS LOCKING UP ON HER. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR COUPLE OF DAYS. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS ALARMING NO DELIVERY AND SHE WAS NOT RECEIVING INSULIN. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 540 MG/DL AND WAS TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A DISPLACEMENT AND SELF TEST AND THE TESTS PASSED. ADVISED THE CUSTOMER TO REVERT TO BACK UP PLAN UNTIL THE REPLACEMENT OF THE INSULIN PUMP ARRIVES. 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-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization