BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 11647705 · Received April 12, 2021

    Report

    Report Number
    2032227-2021-134235
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    April 6, 2021
    Report Date
    February 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000192143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = CLEAR. CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED BLANK DISPLAY FOUND ON (B)(6), 2021. THE INSULIN PUMP WAS RECEIVED WITH BLANK FLASHING WHITE DISPLAY. UNABLE TO PERFORM THE DISPLACEMENT TEST, SLEEP CURRENT TEST, ACTIVE CURRENT TEST AND SELF TEST DUE TO BLANK FLASHING WHITE DISPLAY. THE INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE ON LIQUID CRYSTAL DISPLAY FLEX CONNECTOR (ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2). TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CORNER OF BELT CLIP RAILS, CRACKED CASE (BATTERY TUBE), CRACKED RETAINER, CRACKED BATTERY TUBE THREADS, FADED SERIAL LABEL, CRACKED KEYPAD OVERLAY, AND MINOR SCRATCHES ON LIQUID CRYSTAL DISPLAY WINDOW. IN SUMMARY, CUSTOMER ALLEGATION FOR BLANK DISPLAY WAS CONFIRMED DURING VISUAL INSPECTION WHERE MOISTURE DAMAGE ON LIQUID CRYSTAL DISPLAY FLEX CONNECTOR (ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2) WAS NOTED. 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

    THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. (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 A FLASHING DISPLAY. INSULIN PUMP HAD PUMP ERROR ALARM. CUSTOMER WAS NOT CALLING BACK AFTER INSTALLING A NEW BATTERY AND MONITOR THE INSULIN PUMP FOR TWO HOURS AND FROZEN DISPLAY RECURRED. CUSTOMER CHANGED THE BATTERY OF INSULIN PUMP BUT THAT DID NOT RESOLVE THE ISSUE. 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
    550262 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG3619M 000000763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown