BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105ELBLNA ELI LILY BLUE

    MDR report key: 12874696 · Received November 25, 2021

    Report

    Report Number
    3012822846-2021-00833
    Event Type
    Injury
    Date Received
    November 25, 2021
    Date of Event
    October 28, 2021
    Report Date
    December 20, 2021
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COLOR: BLUE. CUSTOMER REPORTS: I WAS LOADING THE CARTRIDGE I WAS PUTTING THE CAP BACK ON AND THEN CARTRIDGE HOLDER BROKE. IT WON¿T GIVE THE RIGHT AMOUNT. I WOULD TRY TO ADJUST IT AND IT WOULD SQUIRT OUT INSULIN. IT WASN¿T GIVING ME INSULIN. PER VISUAL INSPECTION: BROKEN OFF PIECE AT THE CARTRIDGE HOLDER. SEVERAL ATTEMPTS WERE MADE TO PAIR INPEN, EVERY TIME APP DISPLAYED DOSE DOESN'T MATCH AND INPEN NOT FOUND. THE INPEN DOES NOT PAIR WITH COMMERCIAL MOBILE APP. 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. INPEN DOSE BUTTON WAS REMOVED AND ELECTRONIC STACK, FLEX CONNECTOR AND BATTERY WERE INSPECTED FOR ELECTRICAL FAULTS, MOISTURE DAMAGE, WORKMANSHIP AND CRACKED OR DAMAGE COMPONENTS. A BATTERY TEST WAS PERFORMED AND BATTERY MEASURE AT 0.146 VOLTS. IT WAS DETERMINED THAT THE INPEN DOES NOT PAIR WITH COMMERCIAL MOBILE APP DUE TO DEPLETED BATTERY (0.146 VOLTS). IN CONCLUSION: INPEN BATTERY LIFETIME ITS 1 YEAR AFTER FIRST PARING. IT IS POSSIBLE BATTERY LIFE DECREASED AS EXPECTED. THE CUSTOMER COMPLAINT OF PHYSICAL DAMAGE TO CARTRIDGE HOLDER IS CONFIRMED. HOWEVER, UNABLE TO VERIFY CUSTOMER COMPLAINT OF INPEN NOT GIVING / TRANSMITTING THE RIGHT DIAL AND DOSE AMOUNT OF UNITS TO THE APP DUE TO PAIRING / COMMUNICATION ANOMALY CAUSE BY DEPLETED BATTERY. 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 HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. CUSTOMER WAS TREATED WITH MANUAL INJECTION HIGH BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772069 INPEN MMT-105ELBLNA ELI LILY BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELBLNA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Unknown Other FRN-RSVR,UNOMED INF SET