BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KR 670G MG MEDI RECERT

    MDR report key: 19257388 · Received May 7, 2024

    Report

    Report Number
    2032227-2024-164759
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    March 16, 2024
    Report Date
    May 24, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365912
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED 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 AT 0.08710 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM 10/13/2023 TO 04/05/2024, 04/16/2024 TO 04/18/2024. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARMS/SUSPENDS AND BOLUS/BASAL DELIVERY FOR THE EVENT DATES OF 14-APR-2024, 07-JAN-2023, 01-DEC-2022, 26-DEC-2022, 31-DEC-2022 AND 06-JAN-2023. THERE WAS NO DATA AVAILABLE TO VERIFY NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM FOR THE EVENT DATES OF 07-JAN-2023, 01-DEC-2022, 26-DEC-2022, 31-DEC-2022 AND 06-JAN-2023. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERRORS/ALARMS 1 WEEK PRIOR TO THE EVENT DATES OF 14-APR-2024, 07-JAN-2023, 01-DEC-2022, 26-DEC-2022, 31-DEC-2022 AND 06-JAN-2023 IN THE FORMATTED HISTORY FILE. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE (PRIMARY) EVENT DATE OF 16-MAR-2024, THERE IS NO UNEXPECTED ALARMS/SUSPENDS AND NO BOLUS DELIVERY NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE (PRIMARY) EVENT DATE OF 16-MAR-2024 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME = 03/16/2024 00:00:00.000. DAILYTOTALOFALLINSULINDELIVERED = 0. DAILYTOTALOFBASALINSULINDELIVERED = 0. DAILYTOTALOFBOLUSINSULINDELIVERED = 0. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. THERE WERE NO UNEXPECTED PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE (PRIMARY) EVENT DATE 16-MAR-2024 IN THE FORMATTED HISTORY FILE. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP WITH A BROKEN 1 HEAT STAKE POST. THE ORIGINAL BATTERY CAP LOCKS SECURELY INTO PLACE AND THE PUMP POWERED UP PROPERLY. 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 OVERLAY SCRATCHED, A CRACKED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. CUSTOMER ALLEGED FOR NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOT CON 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. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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. 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 REPORTED HYPERGLYCEMIA, AND A BLOOD GLUCOSE VALUE OF 500 MG/DL. HYPERGLYCEMIA TREATED WITH MANUAL INJECTION/INSULIN PEN, IV INSULIN DRIP (INTRAVENOUS INSULIN INFUSION), DISCONTINUE USE OF INSULIN DELIVERY SYSTEM, HOSPITALIZATION, AND OVERNIGHT STAY. THE EVENT INVOLVED PRODUCT(S) MMT-332A, MMT-1780KR, AND MMT-397A. THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. THE CUSTOMER WAS NOT USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT. THE CUSTOMER DECLINED TO CONTINUE WITH TROUBLESHOOTING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. MMT-1780KR WAS REQUESTED AND THE CUSTOMER RESPONDED THAT THE DEVICE WOULD BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-397A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669588 PUMP MMT-1780KR 670G MG MEDI RECERT AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KR HG4S5KL 000000763000365912

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Hospitalization| R| O FRN-MMT-332A-RSVR, UNOMED INF SET,