BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 14883450 · Received July 1, 2022

    Report

    Report Number
    2032227-2022-255358
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 17, 2019
    Report Date
    July 1, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169999763
    Removal / Correction Number
    Z-0958-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. CORRECTION/REMOVAL NUMBER: Z-0958-2020. (B)(4). S/W 2.9D. UNIT PASSED THE DISPLACEMENT TEST AND SELF TEST. UNIT COMMUNICATED PROPERLY WITH THE GLUCOSE SENSOR SIMULATOR AND THE GUARDIAN 2 LINK SENSOR TRANSMITTER. NO PUMP/SENSOR COMMUNICATION ANOMALY OR CALIBRATION ANOMALY NOTED. PUMP WAS ALSO RETURNED FOR PUMP ERROR 4 PUMP ERROR 53. HISTORY FILE ANALYSIS CONFIRMED PUMP ERROR 4 FOLLOWED BY PUMP ERROR 53 DUE TO SOFTWARE ERROR (LINENUMBER = 72, FILENUMBER = 1, PTC DEFECT NUMBER 1915051). UNIT HAD A PARTIALLY BROKEN RETAINER, A PARTIALLY BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, MISSING DISPLAY WINDOW COVER, SCRATCHED CASE, STAINED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. 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

    MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747416 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K 00643169999763

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown