BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2182466 · Received July 18, 2011

    Report

    Report Number
    3004209178-2011-82190
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    July 3, 2011
    Report Date
    July 4, 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 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. 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 DUE TO HIGH KETONES AND HIGH BLOOD GLUCOSE OF 235MG/DL. IT WAS STATED THAT THE LAST INFUSION SET CHANGE WAS ON (B)(6) 2011. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST TWO DAYS. IT WAS STATED THAT WHEN THE CUSTOMER WAS EATING AND DELIVERING A BOLUS, THE INSULIN PUMP ALARMED NO DELIVERY. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING AND THE ALARM HISTORY REVEALED MULTIPLE NO DELIVERY ALARMS. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE INSULIN PUMP PASSED THE TESTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization SILHOUETTE| UNOMEDICAL INFUSION SET| PARADIGM| MMT-377| FULL| 43