BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2112397 · Received May 26, 2011

    Report

    Report Number
    3004209178-2011-81587
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 14, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPERGLYCEMIA, WITH BLOOD GLUCOSE OF 500 MG/DL. THE CUSTOMER'S MOTHER STATED THAT THE CUSTOMER HAD WOKEN UP THE DAY OF THE EVENT WITH HIGH BLOOD GLUCOSE LEVELS AND HAD BEEN TREATED WITH AN INSULIN PEN AND AN INFUSION SET CHANGE. THE CUSTOMER'S MOTHER THEN STATED THAT WHEN THE INSULIN PUMP WAS PUT ON THE CUSTOMER, HIS BLOOD GLUCOSE WENT BACK UP. THE CUSTOMER'S MOTHER ALSO STATED THAT THE CUSTOMER USES A QUICK-SET INFUSION SET AND CHANGES HIS INFUSION SET EVERY TWO THREE DAYS. PROGRAMMING WAS CORRECT. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE FIXED PRIME 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-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization MODEL MMT-399, LOT 9202163| UNOMEDICAL QUICK-SET INSULIN INFUSION SET: