BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS

    MDR report key: 10407315 · Received August 14, 2020

    Report

    Report Number
    2032227-2020-163300
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    August 9, 2020
    Report Date
    August 14, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169933170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER HAD HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 401 MG/DL AND THE CURRENT BLOOD GLUCOSE WAS 144 MG/DL. THIS MORNING THE BLOOD GLUCOSE WAS 345 MG/DL, 130 MG/DL AND NOW IT WAS 144 MG/DL. THE BLOOD GLUCOSE WENT UP TO 301, 231, 275, 303 MG/DL AND ON SATURDAY IT WAS 319 MG/DL AND 401 MG/DL THE DOWN TO 345 TO 326 MG/DL AND THEN WENT DOWN TO 311, 328, 374 MG/DL AND LAST NIGHT IT WAS STEADY TO 179MG/DL THEN DOWN TO 130 MG/DL. THE CUSTOMER HAD PROBLEMS WITH HIS SUGARS REALLY HIGH UP TO 395 MG/DL. THE CUSTOMER ALSO STATED THAT, THE INSULIN PUMP HAD MOTOR ERROR AND INSULIN PUMP WAS ABLE TO REWIND. THE DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875917 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS A6723LNASJ 000000643169933170

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other FRN-UNK-RSVR,UNOMED.INF.SET