PUMP 1886 780G OUS BLE PUMP MG/DL
Report
- Report Number
- 2032227-2026-128611
- Event Type
- Malfunction
- Date Received
- February 17, 2026
- Date of Event
- January 26, 2026
- Report Date
- April 8, 2026
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000076300073256101
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- 003
Narratives
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 DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. UNABLE TO UPLOAD PUMP TO CARELINK DUE TO A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. ON THE SS EVENT DATE OF 26-JAN-2026, PUMP ERROR 40 ALARM WAS NOTED. UNABLE TO VERIFY DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE SS EVENT DATE OF 26-JAN-2026 LISTED ON SMARTSOLVE DUE TO INSUFFICIENT DATA IN THE TRACE/HISTORY FILES. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM 12/01/2025 TO 01/26/2026. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARM(S)/SUSPENDS AND DAILY TOTAL OF BASAL/BOLUS DELIVERY FOR THE SAP NOTE/CUSTOMER'S EVENT DATE OF 27-JAN-2026. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND PUMP ERROR 40 ALARMS CONFIRMED IN THE FORMATTED HISTORY FILE ON 01/26/2026 10:01:00.000 AND 01/26/2026 10:11:00.000. AS PER GLOBAL LOGIC ANALYSIS (ESF#: 2011913) PUMP ERROR 40 ALARM (FILE NUMBER: 121 LINE NUMBER: 551), SUSPECTED ON SW. IN FURTHER REVIEW OF THE FORMATTED HISTORY FILE 1 WEEK FROM THE SS EVENT DATE OF 26-JAN-2026, THESE PUMP ERROR(S)/ALARM(S) WERE NOTED: LOSTSENSOR1ALERT (780) WAS FOUND ON: 01/20/2026 15:32:00.000, 01/20/2026 15:42:00.000, 01/22/2026 16:52:00.000, 01/25/2026 23:34:00.000. LOW BATTERY ALERT WAS FOUND ON: 01/21/2026 16:50:00.000. INSERT BATTERY ALARM WAS FOUND ON: 01/21/2026 16:47:44.000, 01/21/2026 16:49:33.000, 01/21/2026 16:49:44.000, 01/21/2026 16:50:00.000, 01/21/2026 16:50:09.000, 01/22/2026 13:40:31.000, 01/26/2026 23:06:39.000. 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. UNABLE TO TEST FOR LOST SENSOR ALERT AND LOW BATTERY ALERT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. LOST SENSOR ALERT AND LOW BATTERY ALERT WERE UNKNOWN. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1, PCBA 2 AND MOTOR ASSEMBLY NOTED. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.10 MV). THE PUMP WAS RECEIVED WITHOUT A BATTERY. THE PUMP WAS RECEIVED WITHOUT A BATTERY CAP. THE MOLDING KNIT LINE DAMAGE (NEAR THE BELT CLIP PLATE) WAS ACCEPTABLE PER CASE ASSEMBLY COSMETIC SPECIFICATION, (B)(4). THE TEST SC1 CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A OVERLAY SCRATCHED AND A SCRATCHED CASE. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. UNABLE TO UPLOAD PUMP TO CARELINK AND PERFORM THE REQUIRED TESTING DUE TO A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO FATAL ALARM PUMP ERROR 40. PUMP ERROR 40 ALARM, SUSPECTED ON SW. DURING VISUAL INSPECTION, CORROSION WAS FOUND ON THE PCBA 1, PCBA 2 AND MOTOR 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.
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.
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER RECEIVED AN CRITICAL PUMP ERROR. THE CUSTOMER REPORTED A BLOOD GLUCOSE VALUE OF 387 MG/DL. THE CUSTOMER EXPERIENCED HYPERGLYCEMIA AND TREATED WITH AN INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). THE CUSTOMER EXPERIENCED HYPERGLYCEMIA, DIABETIC KETOACIDOSIS AND TREATED WITH A EMERGENCY ROOM VISIT, AND HOSPITALIZATION: OVERNIGHT STAY. THE SYMPTOMS CUSTOMER REPORTED AT THE TIME OF HOSPITALIZATION EVENT WAS NAUSEA. THE CUSTOMER 'S FAMILY MEMBER ASSISTED IN OBTAINING TREATMENT FOR HIGH BLOOD GLUCOSE EVENT, AND 5 HOURS LONG THE CUSTOMER'S BLOOD GLUCOSE HIGH. THE EVENT INVOLVED PRODUCT(S) MMT-1886. TROUBLESHOOTING WAS PERFORMED FOR THE HIGH BLOOD GLUCOSE. THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS AT THE TIME OF THE EVENT, AND THE AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED FOR THE CRITICAL PUMP ERROR, EXPLAINED THAT THE PUMP PERFORMS SAFETY CHECKS, AND AN ERROR WAS FOUND. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE AND REVERT TO THE BACKUP PLAN WITH THE HEALTH CARE PROFESSIONAL'S INSTRUCTIONS. MMT-1886 WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WOULD BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 426457 | PUMP 1886 780G OUS BLE PUMP MG/DL | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1886 | NG4003115H | 000076300073256101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Unknown |