BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105ELBLNA ELI LILY BLUE

    MDR report key: 13048228 · Received December 20, 2021

    Report

    Report Number
    3012822846-2021-00884
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    December 8, 2021
    Report Date
    April 12, 2022
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    Product Problem
    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: 3.8.4. COLOR: BLUE. BATTERY LIFE REMAINING: < 3 MONTHS. CUSTOMER REPORTS: THE DIAL ITS STUCK. INPEN WILL NOT DISPENSE ANY INSULIN. PER VISUAL INSPECTION: MISSING DOSING WINDOW. THE INPEN PAIRED TO THE COMMERCIAL APP WITH 1.0 U PAIRING DOSE. THE SCREW IS NOT BENT. THE LEADSCREW ADVANCES PROPERLY WHEN DOSING LESS THAT 1.0 UNIT, HOWEVER, WHEN DIALING MORE THAN 1.5 UNITS THE LEADSCREW RETRACTS AND A HIGH RESISTANCE ITS FEEL AT THE DIAL. UNABLE TO PERFORM FUNCTIONAL TEST DUE TO LEADSCREW ANOMALY. IN CONCLUSION: PER SAN DIEGO INVESTIGATION: DESTRUCTIVE TESTING SHOWED THAT LEADSCREW ANOMALY WAS CAUSED BY A PATTERN WHEEL MISALIGNMENT DUE TO AN ENCODER BASE BOND FAILURE. THE CUSTOMER COMPLAINT OF STUCK DIAL AND LEADSCREW ANOMALY 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.

    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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PEN HAD A LEADSCREW ANOMALY. THE CUSTOMER'S MOTHER STATED THAT INSULIN PEN WON'T WORK AND IT WON'T TURN THE DIAL AND IT'S STUCK. IT WAS ALSO REPORTED THAT THEY CHANGED THE CARTRIDGE BUT SAME THING HAPPENED. THE CUSTOMER DID THE TROUBLESHOOT BUT INSULIN DID NOT EXIT NOR THE SCREW MOVED WHEN BUTTON WAS PUSHED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PEN WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939263 INPEN MMT-105ELBLNA ELI LILY BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELBLNA B93UG

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Unknown