BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105NNGYNA NOVO NORDISK GRAY

    MDR report key: 12879686 · Received November 26, 2021

    Report

    Report Number
    3012822846-2021-00839
    Event Type
    Injury
    Date Received
    November 26, 2021
    Date of Event
    November 14, 2021
    Report Date
    December 20, 2021
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER: (B)(6). SOFTWARE VERSION: 3.8.5. COLOR: GREY. BATTERY LIFE REMAINING: <8 MONTHS. CUSTOMER REPORTS: FROM LAST WEEK ITS NOT KEEPING THE ACTIVE INSULIN ON BOARD - WHEN IT SHOULD HAVE, ITS GIVING HER INSULIN MORE - CAUSING TO HAVE A LOW BG - THE LOGS ARE SHOWING BUT THERE WAS AN ACTIVE INSULIN LOG BUT WHEN SHE DOES A BOLUS IT DOES NOT STAY - DOES CAUSING HER TO TAKE MORE INSULIN. PER VISUAL INSPECTION: CRACKED CARTRIDGE HOLDER AND LOOSE CAP. UNIT PAIRED SUCCESSFULLY TO COMMERCIAL APP. INPEN RECEIVED WITH LEADSCREW 1/4 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 CAP DOES NOT FIT SECURELY ONTO CARTRIDGE HOLDER DUE TO SMALL SNAP CRACKED / BROKEN. INPEN CARTRIDGE HOLDER RECEIVED CRACKED, HOWEVER DOES LOCKS PROPERLY TO INPEN. INPEN RECEIVED WORKING AS DESIGN. ACTIVE INSULIN WAS DISPLAYED PROPERLY IN THE INPEN APP. NO MALFUNCTIONS NOTED DURING TESTING THAT COULD AFFECT INSULIN DELIVERY. THE CUSTOMER COMPLAINT OF INPEN APP NOT DISPLAYING ACTIVE INSULIN AT THE APP 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.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 45 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT INSULIN PEN GAVE MORE INSULIN AND DID NOT KEPT ACTIVE INSULIN ON BOARD. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR LOW BLOOD GLUCOSE LEVEL. THE INSULIN PEN WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775854 INPEN MMT-105NNGYNA NOVO NORDISK GRAY SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNGYNA B94WF 000010862088000351

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Unknown Other