BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INPEN/INPEN APP

    MDR report key: 17432713 · Received August 1, 2023

    Report

    Report Number
    2032227-2023-246055
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 6, 2023
    Report Date
    July 31, 2023
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    NDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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

    COMPLAINTS TEXT 07/27/2023 09:50:03 ERP_RFC_USER RELATED (B)(4) COMPLAINTS TEXT 07/27/2023 09:42:17 ERP_RFC_USER RELATED (B)(4) COMPLAINTS TEXT 07/27/2023 09:41:35 HULETK2 CUSTOMER TO BE REACHED IN AN EFFORT TO OBTAIN MISSING EVENT DETAILS, PERFORM TROUBLESHOOTING FOR EVENT REPORTED. EVENT WAS REPORTED AS PART OF SURVEY CONDUCTED BY MDT CUSTOMER MARKETING IN COLLABORATION WITH EXTERNAL VENDOR. VENDOR SENT DETAILS TO OUS/GST AND REROUTED TO US TECH SUPPORT FOR REGISTRATION DUE TO US CUSTOMER IDENTIFIED. OUS/GST WAS NOTIFIED ON JULY 6, 2023, GST THEN NOTIFIED US TECHNICAL SUPPORT ON JULY 24, 2023 AS EVENTS WERE IDENTIFIED AS US CUSTOMERS. PLEASE COMPLETE TWO CONTACT ATTEMPTS AT A LATER TIME. (SURVEY RESULTS WERE RECEIVED FROM CREATIVE MEDICAL RESEARCH AT VELOX) REFERENCED REPORT PROVIDED TO MEDTRONIC CUSTOMER MARKETING EXPERIENCE TEAM ON 07/06/2023 FORWARDED TO MEDTRONIC 24 HOUR TECHNICAL SUPPORT DEPT ON 07/24/2023 ----REPORT---- USER: (B)(6). THE ONLY THING I¿VE STRUGGLED WITH IS THE DIAL SIGHT GLASS BREAKS OFF. DOES NOT EFFECT THE EFFICIENCY OF THE PEN BUT IT IS ANNOYING. OTHERWISE I HAVE NOT HAD ANY PROBLEMS. THE APP ALSO WORKS WELL! ----END REPORT---- (NO OTHER IDENTIFING INFORMATION, UNABLE TO LOCATE ACCOUNT. DOCUMENTING UNDER (B)(4) ACCOUNT. USING MMT-XXX TO FOR THE INPEN APP AS THE OS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337765 INPEN/INPEN APP Calculator, drug dose NDC MEDTRONIC MINIMED IN-PEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown