BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL - TIME INSULIN INFUSION PUMP

    MDR report key: 2243567 · Received September 2, 2011

    Report

    Report Number
    3004209178-2011-82833
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 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 LOW BLOOD GLUCOSE OF 59MG/DL. IT WAS STATED THAT THE CUSTOMER HAD A STROKE AND WAS PARALYZED ON THE RIGHT SIDE OF HIS BODY. IT WAS STATED THAT THE CUSTOMER HAD UNEXPLAINED LOW BLOOD GLUCOSE FOR (B)(6). TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER WAS TREATED WITH A GLUCAGON SHOT. REVIEWED THE PROGRAMMING AND FOUND THAT THE MOTHER CHANGED THE BASAL RATES WHILE THE CUSTOMER WAS IN THE HOSPITAL. THE MOTHER STATED THAT SHE IS NOT SURE IF THE SETTINGS ARE ACCURATE. INSTRUCTED THE MOTHER TO DISCONNECT AND REMOVE THE RESERVOIR TO KNOW IF THE STATUS SCREEN AND RESERVOIR HAS THE SAME AMOUNT OF INSULIN LEFT. THE CALLER STATED THAT INFUSION SET AND RESERVOIR WERE CHANGED. PERFORMED A DISPLACEMENT TEST AND THE TEST PASSED. 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 CO., JUNCOS MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization