BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1992977 · Received February 7, 2011

    Report

    Report Number
    3004209178-2011-80338
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXPERIENCING LOW BLOOD GLUCOSE OF 40 MG/DL, AND PARAMEDICS WERE CALLED. THE CUSTOMER STATED THAT PARAMEDICS MADE HIM DRINK ORANGE JUICE AND HIS GLUCOSE LEVEL BACK UP OVER 40 MG/DL. THE CUSTOMER REFUSED GOING TO THE HOSPITAL. THE CUSTOMER STATED THAT THE SENSOR DID NOT ALERT HIM WHEN HIS GLUCOSE LEVEL WAS LOW. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE INSERTED A NEW SENSOR THE NIGHT BEFORE AND THE INSULIN PUMP ALERTED HIM, BUT THE ALARM WAS NOT RECORDED ON THE ALARM HISTORY. REVIEWED SENSOR ALARM HISTORY AND ALL THE CALIBRATIONS AND ALARMS SHOWED IN THE HISTORY. PERFORMED A SELF TEST AND THE DEVICE PASSED THE TEST. 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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention