BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 10095652 · Received May 28, 2020

    Report

    Report Number
    2032227-2020-123573
    Event Type
    Malfunction
    Date Received
    May 28, 2020
    Date of Event
    May 23, 2020
    Report Date
    June 20, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00763000068998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT RECEIVED WITH CONSTANT PUMP ERROR 63. UNABLE TO PERFORM DISPLACEMENT TEST SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF-TEST OR VERIFY PUMP ERROR 53 ALARM DUE TO PUMP ERROR 63. THUS SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. FOUND MULTIPLE PUMP ERROR 63 ALARM (VARIABLE 15) FILE NUMBER: 522, LINE NUMBER: 341 ON 05/24/2020 10:04:38.000, 05/24/2020 11:59:53.000, 05/24/2020 12:00:31.000 IN THE FILE HISTORY FILES. PUMP 63 ERROR DUE TO HARDWARE ERROR. ALSO, PUMP ERROR 53 ON 05/24/2020 10:05:42.000, 05/24/2020 10:06:00.000 IN FILE HISTORY. NO MOISTURE DAMAGE ON THE ELECTRONICS, BATTERY TUBE, MOTOR, VIBRATOR, AND KEYPAD ASSEMBLY DURING VISUAL INSPECTION. UNIT P-CAP / TEST RESERVOIR LOCK IN PLACE PROPERLY. UNIT HAD SCRATCHED CASE, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY. IN CONCLUSION, UNABLE TO VERIFY PUMP ERROR 53 ALARM DUE TO CONSTANT PUMP ERROR 63. HOWEVER, PUMP ERROR 63 ALARMS IN HISTORY DUE TO HARDWARE ERROR ELECTRONIC DEFECTIVE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED MULTIPLE PUMP ERROR ALARMS. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. CUSTOMER WAS PERFORMING SELF TEST AGAIN HARDWARE LOW LEVEL FAILURE ALARM WAS REOCCURRED. CUSTOMER ALSO STATED THAT THE RETAINER RING AND SELECT BUTTON WERE CRACKED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563239 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG2M72Z 00763000068998

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown