BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1884L MM780G BLE 3.0 MG/ML

    MDR report key: 20890759 · Received December 10, 2024

    Report

    Report Number
    2032227-2024-282643
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    November 14, 2024
    Report Date
    January 8, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO DAMAGE/BROKEN BELT CLIP RAILS NOTED. HOWEVER, DURING VISUAL INSPECTION THE CUSTOMER HAD APPLIED ADHESIVE ON THE BELT CLIP AREA OF THE PUMP. 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 0.08725 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 14-NOV-2024, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. UNABLE TO VERIFY DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 14-NOV-2024 LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. 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. PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 14-NOV-2024 IN THE FORMATTED HISTORY FILE.  LOSTSENSOR1ALERT (780) WAS FOUND ON: 11/14/2024 19:28:00.000, 11/14/2024 19:38:00.000. LOSTSENSOR2ALERT (781) WAS FOUND ON: 11/14/2024 19:54:00.000. SENSORERRORALERT (801) WAS FOUND ON: 11/10/2024 20:57:46.000, 11/14/2024 13:35:24.000. SGCALIBRATIONERROR (776) WAS FOUND ON: 11/14/2024 15:49:24.000, 11/14/2024 15:59:00.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. NO PUMP/TRANSMITTER COMMUNICATION ANOMALY NOTED. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO LOST SENSOR ALERT, SENSOR ERROR ALERT, SG CALIBRATION ERROR OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. THE PUMP PROPERLY PAIRED WITH TEST ACCU-CHEK GUIDE LINK BG METER. THE PUMP COMMUNICATED PROPERLY AND RECORDED THE 90 MG/DL TEST VALUE PROPERLY FROM TEST ACCU-CHEK GUIDE LINK BG METER. NO PUMP/BG METER COMMUNICATION ANOMALY NOTED. NO UNEXPECTED SENSOR GLUCOSE/BLOOD GLUCOSE (SG/BG) ANOMALY NOTED DURING TESTING. LOW BATTERY ALERT WAS FOUND ON: 11/12/2024 19:57:00.000. INSERT BATTERY ALARM WAS FOUND ON: 11/12/2024 21:58:08.000. 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. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 13-NOV-2024 AT 1:55:59 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 12-NOV-2024. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. NO UNEXPECTED LOW BATTERY ALERT NOTED DURING TESTING. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. 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 SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR SENSOR GLUCOSE/BLOOD GLUCOSE (SG/BG) ANOMALY AND HIGH BGS/DKA. CUSTOMER ALLEGED FOR PUMP/TRANSMITTER COMMUNICATION ANOMALY WAS NOT CONFIRMED. COSMETIC DAMAGE AT THE BACKSIDE (ON THE RAILS FOR THE BELT CLIP) WAS NOT CONFIRMED, HOWEVER, OTHER COSMETIC DAMAGE WAS NOTED DURING ANALYSIS. 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 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 HARM REPORTED WITH A REPORTED ALLEGATION OF A DEVICE MALFUNCTION AND THE CUSTOMER REPORTED DAMAGE AT THE RAIL PIECE. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 553 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA AND ELEVATED KETONES/DIABETIC KETOACIDOSIS AND WAS TREATED WITH AN INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION), HOSPITALIZATION: OVERNIGHT STAY, AND MANUAL INJECTION/INSULIN PEN WITH THE SYMPTOMS OF NAUSEA, CHEST PAIN, MALAISE, DEHYDRATION, URINARY FREQUENCY/POLYURIA, THE EVENT INVOLVED PRODUCT(S) MMT-397A, MMT-332A, MMT-1884L, MMT-7040A. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS USING THE AUTO MODE/SMARTGUARD FEATURE AT THE TIME OF THE EVENT ALSO THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BG EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-397A. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. MMT-1884L WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WOULD BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-7040A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505833 PUMP MMT-1884L MM780G BLE 3.0 MG/ML AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884L NG3252156H

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other| H| R FRN-MMT-332A-RSVR,UNOMED INF SET,OZP-MMT-7040A-SNS