BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1712KL 640G V4.10 BK SF MG

    MDR report key: 19275853 · Received May 9, 2024

    Report

    Report Number
    2032227-2024-166016
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 23, 2024
    Report Date
    December 11, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317195
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE DISPLACEMENT TEST AND SELF TEST. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO THE RESERVOIR COMPARTMENT. NO PUMP ERROR 54 AND PUMP ERROR 3 ALARMS WERE NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED PUMP HISTORY FILES AND TRACES USING THUS SOFTWARE. PUMP ALARMED A PUMP ERROR 54 ALARMS (FILE #: 32122, LINE #:1421, ESF #: 3010978) ON THE EVENT DATE OF 23-APR-2024 AT 12:38:11.000 DUE TO A POSSIBLE SOFTWARE ANOMALY. PUMP ALARMED A PUMP ERROR 3 ON THE EVENT DATE OF 23-APR-2024 AT 12:38:13.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, AND FORCE SENSOR. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, STAINED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, PILLOWING KEYPAD OVERLAY, AND LABEL DAMAGE. PUMP ERROR 54 WAS CONFIRMED IN THE PUMP HISTORY FILES AND TRACES DUE TO A SOFTWARE ANOMALY. PUMP ERROR 3 WAS CONFIRMED IN THE PUMP HISTORY FILES AND TRACES AS A CONSEQUENCE OF PUMP ERROR 54. 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 · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE THE UNITED STATES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED PUMP ERROR 3 (THE MAIN ARM CANNOT COMMUNICATE WITH THE MOTOR ARM), AND PUMP ERROR 54 (HAL SOFTWARE ERROR DETECTED). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1712KL. THE CUSTOMER REPORTED RECEIVING A PUMP ERROR 3 AND 54. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ABLE TO CLEAR THE ERROR AND ABLE TO COMPLETE THE PUMP REWIND. THE FILL CANNULA DELIVERY TEST WAS SUCCESSFUL. THE ERROR TABLE DID NOT INDICATE THAT THE PUMP SHOULD BE REPLACED AND THE PUMP PASSED SELF TEST. THE CUSTOMER WAS NOT USING QUICK BOLUS SPEED FEATURE ON AN IMPACTED PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN WAS REQUIRED FOR MMT-1712KL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548353 PUMP MMT-1712KL 640G V4.10 BK SF MG PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712KL NG3208312H 000000763000317195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown