BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105ELGYNA ELI LILY GRAY

    MDR report key: 15648873 · Received October 21, 2022

    Report

    Report Number
    3012822846-2022-01498
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    August 4, 2022
    Report Date
    October 21, 2022
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER REPORTS: THAT THE PEN IS NOT SENDING DOSES TO APP ANYMORE. STATES THERE WAS ALSO AN ISSUE WITH ONE OF HIS CARTRIDGES BECAUSE IT WAS LEAKING FROM THE RUBBER SEAL.PER VISUAL INSPECTION: CAP NO LONGER STAYS ATTACHED. NO PHYSICAL DAMAGE TO CARTRIDGE HOLDER OR INPEN WAS NOTED.THE LEADSCREW WAS RECEIVED HALFWAY IT'S TRAVEL, THE LEADSCREW WAS REWOUND PROPERLY. LEADSCREW 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. SEVERAL ATTEMPTS WERE MADE TO PAIR INPEN, EVERY TIME APP DISPLAYED DOSE DOESN'T MATCH. INPEN CAP DOES NOT FIT SECURELY ONTO CARTRIDGE HOLDER DUE TO SMALL SNAP ARM BEING CRACKED / BROKEN IN CONCLUSION: INPEN WILL NOT TRANSMIT DUE TO A DEAD BATTERY WHICH MEASURED 192MV. THEREFORE, THE CUSTOMER COMPLAINT OF INPEN NOT PARING WAS 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER DID NOT PROVIDE INFORMATION ABOUT SYMPTOMS OF HIGH BLOOD GLUCOSE VALUE AND TREATMENT DETAILS. IT WAS UNKNOWN IF THE CUSTOMER WAS USING AUTO MODE OR NOT AT THE TIME OF INCIDENT. CUSTOMER STATED THAT INSULIN PEN WAS NOT SENDING DOSES TO APP. CUSTOMER STATED THAT THERE WAS ALSO AN ISSUE WITH ONE OF HIS CARTRIDGES BECAUSE IT WAS LEAKING FROM THE RUBBER SEAL, THIS CAUSED THEM HIGH BLOOD GLUCOSE. CUSTOMER REPORTED THEY HAD INSULIN NOT FOUND AND DOSE NOT FOUND APPEAR ON THE APP. TROUBLESHOOTING WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452661 INPEN MMT-105ELGYNA ELI LILY GRAY SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELGYNA B0110 000010862088000320

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other