BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930533 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86726
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED DISPLACEMENT, EXCESSIVE NO DELIVERY, REWIND, BASIC OCCLUSION AND PRIME TESTS. SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP NOTED.

    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

    CUSTOMER CALLED REPORTING THAT SHE HAD JUST SWAPPED OUT HER INSULIN PUMP AND THE NEW ONE WAS DOING SOME STRANGE THINGS. CUSTOMER HAS HAD THREE LOW BLOOD GLUCOSE LEVELS, ALL AROUND THE 48 -55 MG/DL RANGE. LAST NIGHT HER BLOOD GLUCOSE LEVEL WENT UP BUT WENT LOW AGAIN. WHEN SHE WAS CHANGING OUT THE RESERVOIR, DURING THE PRIME PROCESS INSULIN WAS SHOOTING OUT BEFORE IT WAS SUPPOSED TO. CUSTOMER STATED SHE DOES NOT FEEL CONFIDENT WITH THE DEVICE AND WOULD LIKE A REPLACEMENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408790 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR