BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 19432935 · Received May 31, 2024

    Report

    Report Number
    2032227-2024-179905
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    May 26, 2024
    Report Date
    November 4, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT PASSED SELF-TEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT ACCURACY TEST AND DISPLACEMENT TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUMP AND CARELINK. NO ALARMS OR ALERT NOTED DURING TESTING. THE ELECTRONIC ASSEMBLIES AND MOTOR ASSEMBLIES WERE INSPECTED, AND MOISTURE DAMAGE NOTED. THE P-CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE AT THE BATTERY TUBE, CRACKED KEYPAD OVERLAY, MISSING DISPLAY WINDOW COVER, CORRODED BATTERY TUBE, CORRODED MOTOR HOME SWITCH. PLEASE SEE BELOW FOR THE FIRST TEN BOLUSES LISTED ON THE EVENT DATE 26-MAY-2024 IN THE PUMP HISTORY FILE. (B)(6) 2024 01:06:33.000 NORMALBOLUSDELIVERED (220) SYSTEMTIME = 05/26/2024 01:06:33.000 BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) (B)(6) 202401:11:33.000 NORMALBOLUSDELIVERED (220) SYSTEMTIME =(B)(6) 202401:11:33.000 BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) BOLUSAMOUNTDELIVERED: 1750 (0.175 U) (B)(6) 2024 01:16:33.000 NORMALBOLUSDELIVERED (220) SYSTEMTIME = (B)(6) 2024 01:16:33.000 BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) (B)(6) 2024 01:21:33.000 NORMALBOLUSDELIVERED (220) SYSTEMTIME = (B)(6) 2024 01:21:33.000 BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) BOLUSAMOUNTDELIVERED: 1750 (0.175 U) (B)(6) 202401:26:51.000 NORMALBOLUSDELIVERED (220) SYSTEMTIME = (B)(6) 2024 01:26:51.000 BOLUSPROGRAMMINGMETHOD: CL1AUTOBOLUS (9) BOLUSAMOUNTDELIVERED: 7000 (0.7 U) (B)(6) 2024 01:31:35.000 NORMALBOLUSDELIVERED (220) SYSTEMTIME = (B)(6) 2024 01:31:35.000 BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) (B)(6) 2024 01:36:51.000 NORMALBOLUSDELIVERED (220) SYSTEMTIME = (B)(6) 2024 01:36:51.000 BOLUSPROGRAMMINGMETHOD: CL1AUTOBOLUS (9) BOLUSAMOUNTDELIVERED: 6000 (0.6 U) (B)(6) 2024 01:41:35.000 NORMALBOLUSDELIVERED (220) SYSTEMTIME = (B)(6) 2024 01:41:35.000 BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) (B)(6) 2024 01:46:47.000 NORMALBOLUSDELIVERED (220) SYSTEMTIME = (B)(6) 202401:46:47.000 BOLUSPROGRAMMINGMETHOD: CL1AUTOBOLUS (9) BOLUSAMOUNTDELIVERED: 5000 (0.5 U) (B)(6) 2024 01:51:35.000 NORMALBOLUSDELIVERED (220) SYSTEMTIME = (B)(6) 2024 01:51:35.000 BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) BOLUSAMOUNTDELIVERED: 2000 (0.2 U) PUMP PASSED FUNCTIONAL TESTING AND NO ALARMS OR ALERTS NOTED DURING TESTING. POSSIBLE OVER DELIVERY ANOMALY WAS NOT CONFIRMED. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 POSSIBLE OVER DELIVERY ANOMALY. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 58 MG/DL. THE CUSTOMER REPORTED HYPOGLYCEMIA TREATED WITH GLUCOSE/CARB INTAKE. CTHE EVENT INVOLVED PRODUCT(S) MMT-1886. TROUBLESHOOTING WAS PERFORMED. CUSTOMER HAS BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED EVENT. CUSTOMER REPORTED AUTO MODE/SMARTGUARD WAS AUTOMATICALLY DELIVERING INSULIN AT THE TIME OF EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-1886 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299165 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 NG3174938H

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Unknown