BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3830671 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84929
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    UNABLE TO PRIME THE INSULIN PUMP DURING THE PRIME TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. A SCRATCHED LCD WINDOW, CRACKED CASE, CRACKED RESERVOIR TUBE LIP AND BROKEN BELT CLIP SLOT NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS HAVING PROBLEMS WITH THE INSULIN PUMP AND HAD HIGH BLOOD GLUCOSE LEVEL. EVERY TIME SHE TRIED TO REWIND SHE WAS RECEIVING A PRIME/DELIVERY ALARM. DURING TROUBLESHOOTING CUSTOMER STATED THAT SHE HAD DROPPED THE INSULIN PUMP. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS STICKING OUT. BLOOD GLUCOSE LEVEL WAS 347 MG/DL. NO FURTHER INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308301 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR