BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8665580 · Received June 4, 2019

    Report

    Report Number
    2032227-2019-11018
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 29, 2018
    Report Date
    July 16, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169507234
    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. 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.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST. NO MOTOR ERROR ALARM NOTED. MOTOR PASSED MOTOR TEST. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER'S FAMILY REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA AND INSULIN PUMP RECEIVED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT TIME OF INCIDENT WAS UP TO 400 MG/D. THE CUSTOMER WAS TREATED WITH INSULIN PUMP, MANUAL INJECTION. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER REPORTS THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND REVERT TO BACK UP. THE CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460808 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL B5723NALJ 00643169507234

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other FRN-MMT-332-RSVR, UNOMED SET