BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2140442 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-81827
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR LOW BLOOD GLUCOSE OF 33MG/DL. THE CUSTOMER STATED THAT SHE RECEIVED A LOW RESERVOIR ALARM WHILE BEING AT WORK. THE CUSTOMER REFILLED THE RESERVOIR WITH INSULIN AND RECONNECTED, BUT SHE STARTED TO FEEL SICK. THE CUSTOMER CHECKED HER GLUCOSE LEVEL AND IT WAS 33MG/DL. THEN THE CUSTOMER TOOK GLUCOSE TABLETS AND ATE TO BRING HER BLOOD GLUCOSE UP TO 75MG/DL. THE CUSTOMER FELT BETTER AND DROVE HOME, BUT SHE STARTED TO FEEL SICK AGAIN AND HAD TO PULL TO THE SIDE OF THE ROAD. THE CUSTOMER CHECKED HER GLUCOSE LEVEL AGAIN AND DROPPED TO 33MG/DL. THEN THE CUSTOMER ENDED IN THE HOSPITAL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. THE AMOUNT OF INSULIN LEFT IN THE STATUS SCREEN DID NOT MATCH TO THE UNITS LEFT IN THE RESERVOIR. ADVISED CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFO 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-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization