BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6047303 · Received October 21, 2016

    Report

    Report Number
    2032227-2016-33630
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    July 15, 2016
    Report Date
    September 30, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HER BLOOD GLUCOSE WAS 423 MG/DL. THE PATIENT TREATED VIA MANUAL INSULIN INJECTION. TROUBLESHOOTING WAS INITIATED FOR THE INSULIN PUMP AND THERE WERE NO APPARENT ANOMALIES. THE CUSTOMER DID NOT ATTRIBUTE HER ISSUES WITH THE INSULIN PUMP. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699382 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other