BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3760185 · Received April 18, 2014

    Report

    Report Number
    3004209178-2014-83805
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TEST, INCLUDING PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TEST. NO MOTOR ANOMALY NOTED OR RATTLES NOISE DURING REWIND. UNIT HAD SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS TAKEN TO THE EMERGENCY ROOM AND HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 643 MG/DL. CALLER STATED THAT THE CUSTOMER'S INSULIN PUMP HAS A RATTLING LOUD SOUND AT REWIND. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE HIGH-PRESSURE TEST TWICE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237046 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization