BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 13304374 · Received January 20, 2022

    Report

    Report Number
    2032227-2022-104692
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    January 14, 2022
    Report Date
    June 23, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000264727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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.

    Additional Manufacturer Narrative · 0

    RETAINER RING : BLACK. CUSTOMER RETURNED INSULIN PUMP FOR ALLEGED DISPLAY ANOMALY, CRACKED LIQUID CRYSTAL DISPLAY WINDOW FOUND ON (B)(6) 2022. INSULIN PUMP RECEIVED WITH BLANK FLASHING WHITE DISPLAY. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO BLANK FLASHING WHITE DISPLAY. INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND¿NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE¿ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR.¿ SWAPPING OUT TEST BOARDS CONFIRMS BLANK FLASHING WHITE DISPLAY IS DUE TO LIQUID CRYSTAL DISPLAY WINDOW CONTROLLER. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: UNIT HAD SCRATCHED CASE, CRACKED KEYPAD OVERLAY. BLANK FLASHING WHITE DISPLAY IS DUE TO LIQUID CRYSTAL DISPLAY WINDOW CONTROLLER ELECTRICAL BOARD . CRACKED LIQUID CRYSTAL DISPLAY WINDOW NOT CONFIRMED. 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 INSULIN PUMP WAS DROPPED ON FLOOR. CUSTOMER STATED THAT THE INSULIN PUMP SCREEN WAS GLITCHING DUE TO CRACK ON THE SCREEN. CUSTOMER STATED THAT THE INSULIN PUMP RATTLES WHEN THEY SHAKE IT. CUSTOMER STATED THAT THE LOCATION OF DAMAGE WAS ON THE INSULIN PUMP SCREEN AND THE TYPE OF DAMAGE WAS CRACK. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298027 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG48NQA 000000763000264727

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown