BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4143460 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30121
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED WHICH WAS NOT INCLUDED WITH THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED WITH THIS REPORT. THE INSULIN PUMP PASSED DELIVERY VOLUME ACCURACY TEST.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION TEST AND OCCLUSION TES, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHED DISPLAY WINDOW. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY CUSTOMER THAT THEY HAD BEEN HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS ON (B)(6) 2014. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS MG/DL AT TIME OF HOSPITALIZATION AND WAS GIVE INTRAVENOUS INSULIN DRIP WHILE IN THE HOSPITAL. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER STATED BEING UNCOMFORTABLE WITH THE DEVICE AND WOULD LIKE IT REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603317 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization