BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4243710 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50325
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4). REFERENCE MANUFACTURER REPORT NUMBER: 2032227-2014-50326.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER RECEIVED A NO DELIVERY ALARM. THE CUSTOMER STATED THE ALARM OCCURRED WHEN HE ATTEMPTED TO PRIME. THE CUSTOMER'S BLOOD GLUCOSE WAS 50 MG/DL. CUSTOMER HAS TREATED THEIR BLOOD GLUCOSE WITH JUICE. CUSTOMER ALSO STATED THE ALARM WAS RESOLVED BY A RESERVOIR CHANGE. THE CUSTOMER ALSO REQUESTED TO HAVE HIS INSULIN PUMP REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727621 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR