BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4821249 · Received June 5, 2015

    Report

    Report Number
    3004209178-2015-62929
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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. 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.

    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. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON THE DISPLAY WINDOW. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL BEING HOSPITALIZED ON (B)(6) 2015 DUE TO HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER'S BLOOD GLUCOSE WAS 360 MG/DL. SHE COMPLAINED OF SICKNESS AND VOMITING EVERY TWO HOURS. THE CUSTOMER DID NOT OBSERVE ANY SIGNIFICANT EVENTS LEADING TO THE HOSPITALIZATION. SHE WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION, WAS DISCHARGED AND ADVISED TO TREAT WITH MANUAL INJECTIONS IF THE HIGH BLOOD GLUCOSE RECURRED. SHE ALSO REPORTED THAT THE INSULIN PUMP HAD A PROTRUDING DRIVE SUPPORT CAP. SHE WAS UNSURE HOW THE DAMAGE OCCURRED. SHE HAD TAKEN 5 UNITS OF INSULIN AROUND NOON, ATE, HAD BLOOD GLUCOSE OF ABOUT 300 MG/DL, AND TREATED WITH ANOTHER 5 UNITS OF INSULIN. SHE HAD A PEANUT BUTTER SANDWICH, AND HER BLOOD GLUCOSE ROSE TO 464 MG/DL, WHICH SHE TREATED WITH MANUAL INJECTION. SHE WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED TO REPLACE THE INSULIN PUMP AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366066 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization