BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972232 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88644
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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, INCLUDING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME EXCESSIVE NO DELIVERY, AND DISPLACEMENT TESTS. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. NO EXCESSIVE NO DELIVERY ALARMS WERE NOTED. THE DEVICE WAS TESTED WITH A WATER FILLED RESERVOIR AND NO AIR BUBBLE ANOMALIES WERE OBSERVED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE, AS WELL AS BROKEN BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 600 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY. SHE COMPLAINED OF VOMITING, NAUSEA, AND SICKNESS, AND WAS TREATED WITH TWO INTRAVENOUS DROPS FOR INSULIN AND FLUIDS. THE CUSTOMER ALSO RECEIVED PAIN MEDICATION, AND THE BLOOD GLUCOSE READING WAS BROUGHT DOWN TO 184 MG/DL BEFORE SHE WAS DISCHARGED. DURING TROUBLESHOOTING, SMALL AIR BUBBLES WERE REPORTED AND INSULIN DID NOT EXIT THE TUBING DURING MANUAL PRIME. THE CUSTOMER CHECKED THE BOLUS HISTORY, NOTED THAT IT DOES NOT LOOK CORRECT AND THAT SHE SHOULD HAVE RECEIVED MORE INSULIN. NO LEAK WAS OBSERVED. THE DEVICE PASSED THE HIGH PRESSURE TEST. ADVISED THAT THE INSULIN PUMP WAS WORKING AS DESIGNED. PER TROUBLESHOOTING WITH A NEW RESERVOIR, THE DEVICE ALARMED NO DELIVERY WITH MANUAL PRIME. ADVISED REPLACEMENT OF THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447767 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization