BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7690670 · Received July 16, 2018

    Report

    Report Number
    3004209178-2018-92092
    Event Type
    Injury
    Date Received
    July 16, 2018
    Date of Event
    June 13, 2018
    Report Date
    July 16, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169933156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    THE CUSTOMER¿S FAMILY REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OF 400 TO 420 MG/DL. CUSTOMER ALSO HAD BLOOD GLUCOSE LEVEL OF 221, 250 TO 400 MG/DL. CUSTOMER REPORTED THAT THE AIR BUBBLES WAS SEEN TUBING. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533426 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL A6723LNALJ 00643169933156

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other RESERVOIR FRN MMT-332A