BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPEN MMT-105ELPKNA ELI LILY PINK

    MDR report key: 13102174 · Received December 28, 2021

    Report

    Report Number
    3012822846-2021-00919
    Event Type
    Injury
    Date Received
    December 28, 2021
    Date of Event
    December 17, 2021
    Report Date
    April 29, 2022
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER: N/A, SOFTWARE VERSION: N/A, COLOR: PINK, BATTERY LIFE REMAINING: N/A. CUSTOMER REPORTS: APP IS NOT LOGGING DOSES AND NOT PARING TO APP. INSULIN WILL NOT COME OUT. PER VISUAL INSPECTION: NO PHYSICAL DAMAGE NOTED. THE INPEN DOES NOT PAIR WITH COMMERCIAL MOBILE APP. INPEN RECEIVED WITH LEADSCREW 1/4 OF THE TRAVEL. RE-WOUND SCREW. NO DRAG WAS OBSERVED, 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. IN CONCLUSION: PER SAN DIEGO INVESTIGATION FINDINGS: ELECTRONICS DAMAGE AND RUST DUE TO FLUID INGRESS. THEREFORE, INPEN FAILED PARING DUE TO INGRESS OF WATER CORRODING AND CAUSING ELECTRICAL SHORTING AT THE ELECTRONIC ASSEMBLY. THE CUSTOMER COMPLAINT OF APP NOT TRANSMITTING/ PARING IS CONFIRMED DUE TO MOISTURE DAMAGE. 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.

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER: N/A; SOFTWARE VERSION: N/A; COLOR: PINK; BATTERY LIFE REMAINING: N/A. CUSTOMER REPORTS: APP IS NOT LOGGING DOSES. INSULIN WILL NOT COME OUT. PER VISUAL INSPECTION: NO PHYSICAL DAMAGE NOTED. THE INPEN DOES NOT PAIR WITH COMMERCIAL MOBILE APP. INPEN RECEIVED WITH LEADSCREW 1/4 OF THE TRAVEL. RE-WOUND SCREW. NO DRAG WAS OBSERVED, 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. IN CONCLUSION: NO MALFUNCTIONS OF THE MECHANICAL FUNCTION OF INPEN LEADSCREW WAS NOTED DURING TESTING THAT COULD AFFECT INSULIN DELIVERY. THE CUSTOMER COMPLAINT OF INPEN NOT PAIRING WAS CONFIRMED. PENDING FURTHER ANALYSIS THAT WILL BE PERFORM IN SAN DIEGO LOCATION. SAN DIEGO INVESTIGATION FINDINGS: ELECTRONICS DAMAGE AND RUST DUE TO FLUID INGRESS 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING LOW BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 51 MG/DL. CUSTOMER REPORTED THAT INSULIN DID NOT CAME OUT OF INSULIN PEN SO THEY DOSED WITH SYRINGE. THE CUSTOMER DECLINED THE TROUBLESHOOT. THE INSULIN PEN WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998391 INPEN MMT-105ELPKNA ELI LILY PINK SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105ELPKNA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Other