BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1992956 · Received February 7, 2011

    Report

    Report Number
    3004209178-2011-80345
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 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
    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 MOTHER CALLED REQUESTING ASSISTANCE WITH READING THE BOLUS WIZARD AND THE BOLUS HISTORY TO MAKE SURE THE BOLUS WIZARD WAS GIVING THE CORRECT AMOUNT OF INSULIN. THE MOTHER STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS CLIMBING ALL DAY. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER DID NOT TRY A BACK UP PLAN TO TREAT HER BLOOD GLUCOSE. IT WAS STATED THAT THE TIME ON THE INSULIN PUMP WAS INCORRECT. REVIEWED THE PROGRAMMING ON THE DEVICE AND IT SEEMED TO BE CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. THE CUSTOMER'S MOTHER CALLED THE NEXT DAY TO PERFORM THE HIGH PRESSURE TEST AND THE DEVICE PASSED THE TEST. DURING THE CALL, THE MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HEADACHES AND HIGH BLOOD GLUCOSE OF 361 MG/DL. 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-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization