BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4842581 · Received June 12, 2015

    Report

    Report Number
    3004209178-2015-65100
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 26, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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.

    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 SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP HAD A VIBRATE ANOMALY. CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER STATED THAT THE DEVICE DID NOT VIBRATE TO NOTIFY HIM THAT HE WAS HIGH, ALARM DID NOT GO OFF. THE CUSTOMER STATED THAT THE DEVICE DID NOT VIBRATE DURING THE VIBRATE TEST. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS. THE CUSTOMER WENT LOW AS 28 MG/DL AND CORRECTED WITH ORANGE JUICE. CUSTOMER WAS OFFERED TO TROUBLESHOOT BUT DECLINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386326 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 31 YR