BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1714K 630G BLACK MMOL CANADA

    MDR report key: 11956488 · Received June 8, 2021

    Report

    Report Number
    2032227-2021-154057
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    June 3, 2021
    Report Date
    October 31, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000643169782396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE SCREEN IS NOT CLEAR (UNABLE TO SEE CLEARLY) AND COSMETIC DAMAGE (RETAINER RING CHANGED COLOR). THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SEVERELY SCRATCHED LCD WINDOW, STAINED KEYPAD OVERLAY, SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. NO DISCOLORATION OR DAMAGE ON THE RETAILER WAS NOTED. THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. NO PARTIAL DISPLAY OR DISPLAY ANOMALY NOTED. THE DISPLAY IS READABLE HOWEVER, SCRATCHES ON THE LCD WINDOW MAKES THE DISPLAY DIFFICULT TO SEE. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST AND SELF TEST. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. UNABLE TO SEE THE SCREEN IS CONFIRMED. DISPLAY HARD TO SEE IS DUE TO A SEVERELY SCRATCHED LCD WINDOW. COSMETIC DAMAGE (DISCOLORED RETAINER) IS NOT CONFIRMED. THE INSULIN PUMP PASSED ALL REQUIRED TESTING. 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

    (B)(4). 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PARTIAL DISPLAY. CUSTOMER STATED THAT RETAINER RING CHANGED THE COLOR BUT WAS NOT DAMAGED AND THE SCREEN WAS NOT CLEAR. CUSTOMER WAS NOT ABLE TO SEE THE SCREEN CLEARLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859765 PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1714K HG24Q45 000000643169782396

    Patients

    Seq Age Sex Outcome Treatment
    1