BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 19803441 · Received July 23, 2024

    Report

    Report Number
    2032227-2024-208101
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    July 6, 2024
    Report Date
    October 3, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317089
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. SUCCESSFULLY UTILIZED CREST AND THUS TO DOWNLOAD HISTORY FILES, TRACES AND COMLINK3 FILES. UNABLE TO UPLOAD PUMP TO CARELINK DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 06-JUL-2024, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE OF 06-JUL-2024 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME = (B)(6)2024 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED = 27.925 DAILYTOTALOFBASALINSULINDELIVERED = 16.625 DAILYTOTALOFBOLUSINSULINDELIVERED = 11.3 PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 06-JUL-2024 IN THE FORMATTED HISTORY FILE. INSERT BATTERY ALARM WAS FOUND ON: (B)(6)/2024 14:02:28.000, 07/06/2024 14:05:16.000, 07/06/2024 14:13:40.000 (B)(6)2024 14:15:44.000, 07/06/2024 14:19:04.000 (B)(6)2024 17:23:26.000, 07/06/2024 17:23:32.000, (B)(6)2024 17:25:28.000 (B)(6)2024 17:25:30.000, 07/06/2024 17:25:32.000, (B)(6)2024 17:26:32.000 FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: (B)(6)2024 17:23:27.000, 07/06/2024 17:25:27.000 (B)(6)2024 17:25:29.000, 07/06/2024 17:25:31.000 (B)(6)2024 17:26:31.000 POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS EXPECTED DUE TO PUMP BATTERY DOES NOT HAVE ENOUGH POWER. THE CUSTOMER HAD USED A NO POWER/DEPLETED BATTERY. UNABLE TO TEST FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS UNKNOWN. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 35 ALARM CONFIRMED IN THE FORMATTED HISTORY FILE ON (B)(6)2024 13:34:00.000 AND (B)(6)2024 13:44:00.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. CORROSION WAS ALSO FOUND ON THE BATTERY TUBE ASSEMBLY NOTED. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE MOTOR AND VIBRATOR ASSEMBLY NOTED. THE PUMP WAS RECEIVED WITHOUT A BATTERY CAP INSTALLED. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. UNABLE TO VERIFY CUSTOMER ALLEGED FOR DISCOMFORT/HIGH BGS/LOW BGS. UNABLE TO PERFORM THE REQUIRED TESTING AND UPLOAD PUMP TO CARELINK DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO FATAL ALARM PUMP ERROR 35. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 35 ALARM CONFIRMED DUE TO CORROSION ON THE PCBA 1, PCBA 2 AND FORCE SENSOR. DURING VISUAL INSPECTION, CORROSION WAS ALSO FOUND ON THE BATTERY TUBE ASSEMBLY NOTED. 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

    THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. 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 35(A BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY). THE CUSTOMER REPORTED DISCOMFORT TREATED WITH EMS/AMBULANCE/ER VISIT. THE EVENT INVOLVED PRODUCT(S) MMT-1711K. THE CUSTOMER REPORTED A CRITICAL PUMP ERROR OTHER THAN THE OPEN BOOK IMAGE ERROR OR CRITICAL PUMP ERROR 24. TROUBLESHOOTING WAS NOT PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-1711K WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906157 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG5L2GY 000000763000317089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown