BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105NNPKNA NOVO NORDISK PINK

    MDR report key: 16821658 · Received April 27, 2023

    Report

    Report Number
    3012822846-2023-00910
    Event Type
    Injury
    Date Received
    April 27, 2023
    Date of Event
    March 1, 2023
    Report Date
    June 4, 2023
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000368
    PMA / PMN Number
    K201337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER VISUAL INSPECTION, FONT SHELL DOES NOT FIT SECURELY TO INPEN AND CRACKED CARTRIDGE HOLDER. SEVERAL ATTEMPTS WERE MADE TO PAIR INPEN, EVERY TIME APP DISPLAYED ¿INPEN NOT FOUND¿. THE INPEN DOES NOT PAIR WITH COMMERCIAL MOBILE APP. HOWEVER, INPEN DID TRANSMIT TO MANUFACTURING APP. INPEN PASSED FRONT CAP INVESTIGATION. (BATTERY MEASURING 2.9 VOLTAGE). BASE LINE FUNCTIONALITY TEST AND DISPLACEMENT DOSE ACCURACY WERE NOT PREFORMED DUE TO INJECTION BUTTON AND DOSE DETENT REMOVAL. THE ELECTRONIC WAS PROVEN TO BE FUNCTIONAL AND PRODUCED A HEALTHY ENCODER SIGNAL WHEN THE MECHANICAL COMPONENTS OF THE ENCODER WERE REMOVED FROM THE SYSTEM. THE FACT THAT THE RANDOM AND NOISY PULSES WERE OBSERVED PRIOR TO DISASSEMBLY CAN BE AN INDICATION THAT THE CONTACT SPRINGS ON THE ENCODER CONTACT BOARDS WERE NOT TOUCHING THE CONTACTS ON THE PATTERN WHEEL OR NOT EXERTING ENOUGH PRESSURE TO MAKE ELECTRICAL CONNECTION TO PRODUCE CONSISTENT ENCODER PULSES. THEREFORE, THE CUSTOMER CONCERN OF DOSES NOT TRANSMITTING TO APP WAS CONFIRMED. BASE LINE FUNCTIONALITY TEST AND DISPLACEMENT DOSE ACCURACY WERE NOT PREFORMED DUE TO INJECTION BUTTON AND DOSE DETENT REMOVAL. BATTERY MEASURED 3.00V. CRACKED CARTRIDGE HOLDER. THE ELECTRONIC WAS PROVEN TO BE FUNCTIONAL AND PRODUCED A HEALTHY ENCODER SIGNAL WHEN THE MECHANICAL COMPONENTS OF THE ENCODER WERE REMOVED FROM THE SYSTEM. THE FACT THAT THE RANDOM AND NOISY PULSES WERE OBSERVED PRIOR TO DISASSEMBLY CAN BE AN INDICATION THAT THE CONTACT SPRINGS ON THE ENCODER CONTACT BOARDS WERE NOT TOUCHING THE CONTACTS ON THE PATTERN WHEEL OR NOT EXERTING ENOUGH PRESSURE TO MAKE ELECTRICAL CONNECTION TO PRODUCE CONSISTENT ENCODER PULSES. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 466 MG/DL AT THE TIME OF THE EVENT AND HYPOGLYCEMIA WITH AN UNKNOWN BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT.  THE CUSTOMER ALSO REPORTED THAT THE DOSES WERE NOT BEING TRANSMITTED TO THE INPEN APPLICATION. TROUBLESHOOTING WAS PARTIALLY PERFORMED AND FOUND THAT THE CUSTOMER WAS TREATED THE HIGH AND LOW BLOOD WITH A MANUAL INJECTION AND FOOD INTAKE RESPECTIVELY. THE CUSTOMER WAS NOT REPORTING SYMPTOMS AS A RESULT OF BLOOD GLUCOSE. IT WAS FOUND THAT THE INPEN WAS LISTED IN THE ACTIVE SECTION AND THE UNITS WERE SHOWN IN THE LOGBOOK. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INPEN. THE INPEN WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559319 INPEN MMT-105NNPKNA NOVO NORDISK PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNPKNA B1441 000010862088000368

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other