BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 17621766 · Received August 25, 2023

    Report

    Report Number
    2032227-2023-261611
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    April 14, 2023
    Report Date
    August 25, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317089
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2032227-060322-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. CUSTOMER RETURNED PUMP FOR ALLEGED INTERNAL SERIAL NUMBER MISSING AND COSMETIC DAMAGE LOCATED AT THE SERIAL NUMBER LABEL FOUND ON (B)(6) 2023. THE PUMP PASSED THE DISPLACEMENT TEST AND P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. THE INTERNAL SERIAL NUMBER MATCHED THE SERIAL NUMBER ON THE BARCODE AND ON SMARTSOLVE. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: BATTERY CAP CONTACT DAMAGED, SCRATCHED CASE, CRACKED CASE, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, PILLOWING KEYPAD OVERLAY, SERIAL NUMBER LABEL MISSING, KEYPAD OVERLAY TEXTURE DAMAGE, AND END CAP ADDRESS LABEL MISSING. INTERNAL SERIAL NUMBER MISSING WAS NOT CONFIRMED DURING TESTING. COSMETIC DAMAGE WAS CONFIRMED AT THE SERIAL NUMBER LABEL. BATTERY CAP CONTACT DAMAGED WAS CONFIRMED DURING VISUAL INSPECTION. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE THE UNITED STATES. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED MISSING SERIAL NUMBER IN THE STATUS SCREEN. TROUBLESHOOTING WAS PERFORMED AND "ADVISED" TO REPLACE THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP AND THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802979 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG489U6 000000763000317089

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown