BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN MMT-105NNBLNA NOVO NORDISK BLUE

    MDR report key: 11922873 · Received June 2, 2021

    Report

    Report Number
    3012822846-2021-00471
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    October 6, 2020
    Report Date
    June 9, 2021
    Manufacturer
    COMPANION MEDICAL INC
    Product Code
    FMF
    UDI-DI
    000010862088000344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    "UNIT PAIRED SUCCESSFULLY TO COMMERCIAL APP. MY INPEN MENU DISPLAYED: THE FOLLOWING TEST VALUES WERE DIALED AND DOSED: 5.0 U AND RECORD 2.0 U; 5.0 U AND RECORD 1.0 U; 10.0 U DID NOT RECORD; 16.0 U RECORD 2.5 U; THE MOST PROBABLE RPPT CAUSE IS A FAULTY ENCODER." THIS MDR IS RELATED TO THE RETROSPECTIVE REVIEW OF COMPLAINTS FROM COMPANION MEDICAL INC, FOLLOWING MEDTRONIC¿S ACQUISITION OF THE COMPANY IN (B)(6) 2020. 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 · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THIS MDR IS RELATED TO THE RETROSPECTIVE REVIEW OF COMPLAINTS FROM COMPANION MEDICAL INC, FOLLOWING MEDTRONIC¿S ACQUISITION OF THE COMPANY IN SEPTEMBER 2020.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THERE WERE INACCURACIES BETWEEN THE DOSES INTENDED AND DOSES RECORDED. THE DOSES WERE USUALLY GREATER THAN 1.0 UNIT OF INSULIN. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PEN WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822641 INPEN MMT-105NNBLNA NOVO NORDISK BLUE SYRINGE, PISTON FMF COMPANION MEDICAL INC MMT-105NNBLNA B92LE 000010862088000344

    Patients

    Seq Age Sex Outcome Treatment
    1