BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105ELPKNA ELI LILY PINK

    MDR report key: 17341184 · Received July 18, 2023

    Report

    Report Number
    3012822846-2023-01301
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    June 19, 2023
    Report Date
    October 29, 2024
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000337
    PMA / PMN Number
    K201337
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. PER VISUAL INSPECTION: BROKEN OFF PIECE AT THE CARTRIDGE HOLDER AND INPEN FRONT SHELL DOES NOT STAY ATTACHED. UNIT PAIRED SUCCESSFULLY TO COMMERCIAL APP. INPEN RECEIVED WITH LEADSCREW 1/4 OF TRAVEL. CARTRIDGE HOLDER BROKEN OFF PLASTIC PIECES STUCK INSIDE INPEN/CARTRIDGE HOLDER CAVITY. INPEN FAILED FRONT CAP INVESTIGATION. INPEN FRONT SHELL DOES NOT FIT SECURELY ONTO CARTRIDGE HOLDER DUE TO SMALL SNAP ARM BEING CRACKED / BROKEN. TEST INPEN WAS USED TO PERFORM FRONT CAP INVESTIGATION. IN CONCLUSION: INPEN RECEIVED WITH BROKEN OFF PIECE AT THE CARTRIDGE HOLDER. PHYSICALLY DAMAGED CARTRIDGE HOLDERS CAN AFFECT INSULIN DELIVERY. THE CUSTOMER CONCERN OF PHYSICAL DAMAGE AT CARTRIDGE HOLDER WAS CONFIRMED. CAP ANOMALY WAS CONFIRMED. COSMETIC DAMAGE WAS NOT 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

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED BROKEN CARTRIDGE HOLDER OF INPEN. CUSTOMER ALSO REPORTED HYERGLYCEMIA WITH BLOOD GLUCOSE VALUE OF 420 MG/DL. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED FOR FAILURE ANALYSIS.

    Description of Event or Problem · 0

    UPDATED SUMMERY: THE Z101 RFR WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802610 INPEN MMT-105ELPKNA ELI LILY PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELPKNA B1626 000010862088000337

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Other