BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LCMS

    MDR report key: 13731082 · Received March 11, 2022

    Report

    Report Number
    2032227-2022-127990
    Event Type
    Injury
    Date Received
    March 11, 2022
    Date of Event
    December 6, 2021
    Report Date
    June 10, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169533776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. THE INFORMATION THAT WAS PROVIDED WITH THE INITIAL REPORT WAS INCORRECT.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER CHANGED RESERVOIR IN THE MORNING, LATER CUSTOMER WANTED INSULIN BUT IT APPEARED THAT THEY HAD RECEIVED SIXTY UNITS. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER CHANGED THE SET ON THE MORNING OF (B)(6) 2021 AND THAT AS SHE WAS ABOUT TO GIVE HERSELF A BOLUS, SHE NOTICED THE RESERVOIR WAS OUT OF THE PUMP. SHE PUT IT BACK IN AND HAD A BIG SURGE OF INSULIN. SHE SAID IT APPEARED TO HAVE GIVEN HER 60 UNITS WHEN IT SHOULD HAVE MAYBE GIVEN 1 UNIT. SHE SAID THERE WAS NO LEAKING AND SHE FELT A BURN. SHE WENT TO THE HOSPITAL AND WAS HOSPITALIZED ON (B)(6) 2021. IN THE HOSPITAL, BLOOD GLUCOSE WAS IN THE 2MMOL/L RANGE. SHE SAID SHE HAD INCONSISTENT BLOOD GLUCOSE SINCE THEN, WHERE FROM TIME TO TIME SHE HAD TO USE INJECTIONS. CUSTOMER ALLEGED OVER DELIVERY. INSULIN PUMP WAS USED AT THE TIME OF THE INCIDENT. CUSTOMER USES COMPETITOR'S SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221410 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LCMS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754LCMS A1754LCMSJ 000000643169533776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown