BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105NNBLNA NOVO NORDISK BLUE

    MDR report key: 13254385 · Received January 13, 2022

    Report

    Report Number
    3012822846-2022-00034
    Event Type
    Injury
    Date Received
    January 13, 2022
    Date of Event
    December 30, 2021
    Report Date
    February 9, 2022
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    SERIAL NUMBER: (B)(6). SOFTWARE VERSION: 3.8.5. COLOR: BLUE. BATTERY LIFE REMAINING: <7 MONTHS CUSTOMER REPORTS: LEADSCREW NOT WORKING AS INTENDED, NOT DELIVERING PROPERLY. PER VISUAL INSPECTION: INPEN RECEIVED WITH INSULIN CARTRIDGE INSTALLED. NO PHYSICAL DAMAGE TO INJECTION FOOT OR INPEN WAS NOTED. UNIT PAIRED SUCCESSFULLY TO COMMERCIAL APP. INPEN RECEIVED WITH LEADSCREW 1/2 OF THE TRAVEL. RE-WOUND SCREW. NO DRAG WAS OBSERVED, THE SCREW WAS NOT BENT, ADVANCED WHEN DOSAGE KNOB WAS PRESSED DIALING A DOSAGE AND RETRACTED APPROPRIATELY. NO RESISTANCE WAS OBSERVED WHEN DOSING WITHOUT A CARTRIDGE INSTALLED. THE SCREW ADVANCED EVERY TIME 30.0U WAS DIALED AND DOSED UNTIL THE SCREW REACHED MAX EXTENSION. IN CONCLUSION: INPEN RECEIVED WORKING AS DESIGN. NO MALFUNCTIONS NOTED DURING TESTING THAT COULD AFFECT INSULIN DELIVERY. THE CUSTOMER COMPLAINT OF LEADSCREW ANOMALY COULD NOT BE CONFIRMED. 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.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE UP TO 400 MG/DL. THE CURRENT BLOOD GLUCOSE OF THE CUSTOMER WAS 304 MG/DL. THE CUSTOMER STATED THAT THE DEVICE WAS NOT GIVING INSULIN. CUSTOMER STATED THAT THE INSULIN WAS NOT EXITED FROM THE DEVICE. TROUBLESHOOTING WAS PERFORMED BUT ISSUE WAS NOT RESOLVED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332400 INPEN MMT-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNBLNA B0093 000010862088000344

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown Other