BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3121177 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93772
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH ALL OPERATING CURRENTS WITHIN SPECIFICATIONS. THE DEVICE PASSED THE SELF, OFF NO POWER, DISPLACEMENT, REWIND, AND BASIC OCCLUSION TEST. THE RESERVOIR ICON FUNCTIONED PROPERLY. HOWEVER, THE INSULIN PUMP WAS UNABLE TO PRIME DUE TO A FAULTY FORCE SENSOR. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY. THE DEVICE WAS RECEIVED WITH BROKEN BELT CLIP SLOT, SCRATCHED DISPLAY WINDOW, AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 700MG/DL. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 74MG/DL. THE CALLER MENTIONED THAT THE RESERVOIR WAS FOUND TO BE DAMAGED, AND THE RESERVOIR ICON WAS STUCK. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE PISTON DOES NOT MOVE UP OR DOWN, AND THERE IS A SMALL CRACK FROM TOP TO BOTTOM ON THE LEFT SIDE OF THE DEVICE. IT WAS STATED THAT HER PARENTS FOUND HER ON THE BATHROOM FLOOR AND HER SISTER HAD TO DRESS HER BEFORE TAKEN TO THE HOSPITAL. THE CALLER ALSO STATED THAT THE SCREEN IS CRACKED AND THE CUSTOMER PLAYS SOCCER. ADVISED THE MOTHER TO DISCONTINUE THE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221383 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization