BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5103187 · Received September 25, 2015

    Report

    Report Number
    2032227-2015-48868
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 6, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE NURSE REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2015 FOR HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS AROUND 700 MG/DL AT THE TIME OF ADMISSION. IT WAS ALSO FOUND THE CUSTOMER'S BLOOD GLUCOSE ROSE TO 1000 MG/DL DURING THE EVENT. THE CAUSE OF THE CUSTOMER'S HOSPITALIZATION WAS FROM DIABETIC KETOACIDOSIS. THE NURSE REPORTED THE INSULIN PUMP WAS REMOVED FROM THE CUSTOMER'S BODY AT THE TIME OF ADMISSION. TROUBLESHOOTING DID NOT OCCUR AT THE TIME OF THE CALL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634197 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization