BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNBLNA NOVO NORDISK BLUE

    MDR report key: 13851916 · Received March 22, 2022

    Report

    Report Number
    3012822846-2022-00489
    Event Type
    Malfunction
    Date Received
    March 22, 2022
    Date of Event
    January 8, 2022
    Report Date
    April 4, 2022
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. SERIAL NUMBER: N/A, SOFTWARE VERSION: N/A, COLOR: BLUE, BATTERY LIFE REMAINING: N/A. CUSTOMER REPORTS: CAN DIAL ANY NUMBER HOWEVER IT WILL ONLY DISPENSE AT 4.0 U. PER VISUAL INSPECTION: 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. LEADSCREW RECEIVED FULLY RE-WOUND. THE INPEN SCREW RETRACTS WHEN DIALING AND ADVANCES WHEN TURNING DOSE KNOB AND HIGH RESISTANCE WHILE DISPENSING AND DIALING NOTED. HARD TO DIAL MORE THAN 4 UNITS. IN CONCLUSION: THE CUSTOMER COMPLAINT OF HARD TO TURN THE DIAL AND LEADSCREW ANOMALY IS CONFIRMED. HOWEVER, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. PENDING FURTHER ANALYSIS THAT WILL BE PERFORM IN SAN DIEGO LOCATION.

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER: N/A. SOFTWARE VERSION: N/A. COLOR: BLUE. BATTERY LIFE REMAINING: N/A. CUSTOMER REPORTS: CAN DIAL ANY NUMBER HOWEVER IT WILL ONLY DISPENSE AT 4.0 U. PER VISUAL INSPECTION: 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. LEADSCREW RECEIVED FULLY RE-WOUND. THE INPEN SCREW RETRACTS WHEN DIALING AND ADVANCES WHEN TURNING DOSE KNOB AND HIGH RESISTANCE WHILE DISPENSING AND DIALING NOTED. HARD TO DIAL MORE THAN 4 UNITS. IN CONCLUSION: THE CUSTOMER COMPLAINT OF HARD TO TURN THE DIAL AND LEADSCREW ANOMALY IS CONFIRMED. HOWEVER, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. PENDING FURTHER ANALYSIS THAT WILL BE PERFORM IN SAN DIEGO LOCATION. PER NETA GLASER: DESTRUCTIVE TESTING SHOWED A PATTERN WHEEL MISALIGNMENT DUE TO AN ENCODER BASE BOND FAILURE. 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

    MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989190 INPEN MMT-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNBLNA B0081 000010862088000344

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Unknown