BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2123166 · Received June 10, 2011

    Report

    Report Number
    3004209178-2011-81729
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 CUSTOMER REPORTED BEING HOSPITALIZED FOR HYPERGLYCEMIA, WITH BLOOD GLUCOSE OF 697 MG/DL. THE CUSTOMER STATED THAT HIS DOCTOR HAD INFORMED HIM THAT HIS INSULIN PUMP WAS NOT WORKING PROPERLY. THE CUSTOMER THEN MENTIONED THAT HE HAD GONE THROUGH AN X-RAY WHILE WEARING THE INSULIN PUMP AND THAT THE INSULIN PUMP HAD GIVEN ALARMS SINCE. 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 22 YR Hospitalization