BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4803139 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-60161
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 2, 2015
    Report Date
    May 7, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED NO DELIVERY AT LEAST 3 TIMES. THE CUSTOMER ALSO REPORTED EXPERIENCING HIGH BLOOD GLUCOSE. HE STATED THAT THE INSULIN PUMP ALARMED, SHOWING A BLACK CIRCLE ON THE DISPLAY, WHICH COULD NOT BE RESET. HE NOTED THAT THERE WAS SOMETHING WRONG WITH THE CANNULA AND THAT HE COULD NOT LOWER HIS BLOOD GLUCOSE EFFECTIVELY. THE CUSTOMER'S BLOOD GLUCOSE WAS 138 MG/DL. HE NOTED SYMPTOMS OF HIGH BLOOD GLUCOSE IN HIS EYES. HE TREATED WITH MANUAL INJECTION AND CHANGED THE SET THRICE ALREADY. HE REQUESTED TO BYPASS THE TROUBLESHOOT PROCEDURE. HE STATED THAT HE WAS UNABLE TO CHANGE THE INFUSION SET AT THE TIME OF THE CALL. HE STATED THAT THE INSULIN PUMP WAS WORKING AT THE TIME OF THE CALL; HE CALLED THE NEXT DAY, STATING HE HAD CONFIRMED WITH HIS DOCTOR THAT THE DEVICE'S PROGRAMMING WERE CORRECT. THE CUSTOMER'S MOST RECENT BLOOD GLUCOSE WAS 125 MG/DL. HE STATED HE STILL HAD HIGH BLOOD GLUCOSE AND REQUESTED REPLACEMENT OF THE INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347252 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR