BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4173274 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29924
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 15, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECS. THE DEVICE WAS RECEIVED WITH A MINOR LCD WINDOW AND CASE.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE HAS BEEN HAVING ISSUE WITH LOW BLOOD GLUCOSE RECENTLY. HE SPOKE TO HIS DOCTOR, WHO TOLD HIM TO ASK FOR A REPLACEMENT INSULIN PUMP. CUSTOMER STATED HE HAS HAD ISSUES WITH THE INSULIN PUMP. SEVERAL TIMES HE WOULD GO LOW AND BREAK OUT IN A COLD SWEAT, AND THEN HE WOULD GO HIGH. CUSTOMER STATED HE WAS HOSPITALIZED ABOUT FIVE WEEKS AGO FOR HIGH BLOOD GLUCOSE. HIS BLOOD GLUCOSE WAS OVER 800 MG/DL WHEN ADMITTED. CUSTOMER HAD GONE TO THE BATHROOM AT NIGHT AND FELL. HE WAS TREATED WITH AN INSULIN DRIP. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH AND LOW BLOOD GLUCOSE. HIS LAST BLOOD GLUCOSE WAS 123 MG/DL. THE DEVICE IS BEING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603680 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization