BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4962239 · Received August 3, 2015

    Report

    Report Number
    2032227-2015-24811
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    July 12, 2015
    Report Date
    July 13, 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER'S NURSE REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED WITH A BLOOD GLUCOSE LEVEL OF 466 MG/DL. NURSE REPORTED THAT THE REASON FOR THE HOSPITALIZATION WAS NOT THE HIGH BLOOD GLUCOSE LEVEL, BUT NON-DIABETES RELATED CHEST PAINS. THE NURSE WANTED TO VERIFY THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 85 MG/DL. THE CUSTOMER DECLINED TO COMPLETE TROUBLESHOOTING AND WAS ADVISED TO MONITOR THE INSULIN PUMP. THE DEVICE WILL NOT BE REPLACED OR RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504821 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization