BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4866984 · Received June 24, 2015

    Report

    Report Number
    3004209178-2015-68472
    Event Type
    Injury
    Date Received
    June 24, 2015
    Date of Event
    October 1, 2014
    Report Date
    February 10, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN PROVIDED BY FAILURE ANALYSIS THAT WAS NOT INCLUDED ON THE INITIAL DEVICE EVALUATION: THE INSULIN PUMP PASSED THE DISPLACEMENT ACCURACY TEST.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    HE CUSTOMER REPORTED VIA PHONE CALL THAT HE WAS HOSPITALIZED ON (B)(6) 2014 AND WAS TAKEN TO THE EMERGENCY ROOM. CUSTOMER HAD GIVEN HIMSELF 10 TIMES OF WHAT HE SHOULD HAVE GIVEN. CUSTOMER THOUGHT THAT HE CAUSED THE LOW. CUSTOMER HAD ALSO BEEN IN A CAR ACCIDENT FROM PASSING OUT WITH LOW BLOOD GLUCOSE ON (B)(6) 2015. CUSTOMER HAD GONE TO THE VET'S OFFICE FOR PAPERWORK AND PASSED OUT WHILE DRIVING ON THE WAY HOME. CUSTOMER WAS THE DRIVER AND WOKE UP IN THE AMBULANCE. CUSTOMER WAS TAKEN HOME AND NOT TAKEN TO THE HOSPITAL. CUSTOMER WAS ALSO HOSPITALIZED IN OCTOBER OR (B)(6) 2014 BECAUSE, HE HADN'T EATEN IN A LONG TIME AND WAS LOW. CUSTOMER DECLINED TO TROUBLESHOOT FOR THE LOWS. CUSTOMER ALSO DROPPED HIS PUMP IN THE TOILET AND HAD A BATTERY OUT LIMIT ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 180 MG/DL. THE PUMP PASSED THE DISPLACEMENT TEST AND THE SELF TEST. CUSTOMER HAS A BLACK BORDER AROUND THE SCREEN. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED AND REVERT TO A BACK-UP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408295 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization