BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3791180 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-84346
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 FUCNTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE DRIVE SUPPORT WAS INSPECTED AND NO ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER IS EXPERIENCING HIGH BLOOD GLUCOSE. CUSTOMER WENT TO BED WITH BLOOD GLUCOSE OF 150 MG/DL. WOKE UP IN THE MORNING WITH A BLOOD GLUCOSE READING OF 440 MG/DL. THE BASAL RATE WAS OKAY. CUSTOMER HAD CORRECTED THE HIGH WITH A MANUAL INJECTION. THE CURRENT BLOOD GLUCOSE READING IS 397 MG/DL. CUSTOMER TREATED WITH A BOLUS. CUSTOMER WAS VOMITING, EXHAUSTED AND THIRSTY. CUSTOMER REPORTED A LOW BLOOD GLUCOSE EVENT. CUSTOMER HAD A SEIZURE WITH A LOW BLOOD GLUCOSE OF 20 MG/DL. THE PHYSICIAN HAD CHANGED THE SETTINGS AND CAUSED THE LOW. THE SETTINGS WERE CHANGED AGAIN AND SHE WENT HIGH TO 400 MG/DL. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP IS FLUSH. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268354 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 62 YR