BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4223181 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-47191
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PATIENT

    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. HE STATED HE HAD WOKEN UP WITH A BLOOD GLUCOSE OF 480 MG/DL. THE CUSTOMER ALSO STATED HIS INSULIN PUMP HAD SEVERAL NO DELIVERY ALARMS. THE CUSTOMER ALSO REPORTED A HOSPITALIZATION EVENT ON (B)(6) 2014. IT WAS FOUND THE CUSTOMER HAD A LARGE KETONES AND HIS BLOOD GLUCOSE WAS 600 MG/DL AT THE TIME OF ADMISSION. CUSTOMER ALSO STATED HE WAS VOMITING AND HAD DRY MOUTH PRIOR TO THE HOSPITALIZATION. IT WAS ALSO FOUND THE CAUSE OF HOSPITALIZATION WAS DUE TO DIABETES KETOACIDOSIS. THE CUSTOMER STATED HE WAS HOSPITALIZED FOR TWO NIGHTS WITH AN INSULIN DRIP FOR TREATMENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705996 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization