MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
Report
- Report Number
- 2032227-2021-223710
- Event Type
- Injury
- Date Received
- November 29, 2021
- Date of Event
- November 16, 2021
- Report Date
- August 16, 2022
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000384258
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
RETAINER RING = BLACK THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S, AND UNDER DELIVERY ANOMALY ON (B)(6) 2021. THE DEVICE PASSED THE FUNCTIONAL TEST, 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 THE DAT AT 0.071 INCHES. NO UNDER DELIVERY ANOMALY NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THERE WAS 237 BOLUSES LISTED ON THE EVENT DATE IN THE DEVICE HISTORY FILE. PLEASE SEE THE FIRST 10 BOLUSES LISTED BELOW ON THE EVENT DATE IN THE DEVICE HISTORY FILE. (B)(6) 2021 00:05:01.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 250 (0.025 U) BOLUSAMOUNTDELIVERED: 250 (0.025 U) (B)(6) 2021 00:05:09.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 500 (0.05 U) BOLUSAMOUNTDELIVERED: 500 (0.05 U) (B)(6) 2021 00:10:19.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2750 (0.275 U) BOLUSAMOUNTDELIVERED: 2750 (0.275 U) (B)(6) 2021 00:15:19.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2750 (0.275 U) BOLUSAMOUNTDELIVERED: 2750 (0.275 U) (B)(6) 2021 00:20:19.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2750 (0.275 U) BOLUSAMOUNTDELIVERED: 2750 (0.275 U) (B)(6) 2021 00:25:19.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2750 (0.275 U) BOLUSAMOUNTDELIVERED: 2750 (0.275 U) (B)(6) 2021 00:30:17.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2500 (0.25 U) BOLUSAMOUNTDELIVERED: 2500 (0.25 U) (B)(6) 2021 00:35:19.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2750 (0.275 U) BOLUSAMOUNTDELIVERED: 2750 (0.275 U) (B)(6) 2021 00:40:19.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2750 (0.275 U) BOLUSAMOUNTDELIVERED: 2750 (0.275 U) (B)(6) 2021 00:45:19.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5) NORMALBOLUSAMOUNTPROGRAMMED: 2750 (0.275 U) BOLUSAMOUNTDELIVERED: 2750 (0.275 U) THERE WAS NO AUTO SUSPEND ALARM, USER SUSPENDED ALARM OR PUMP ERRORS NOTED ON THE EVENT DATE IN THE DEVICE HISTORY FILE. THE DEVICE PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BG'S. THE CUSTOMER ALLEGED POSSIBLE UNDER DELIVERY ANOMALY WAS NOT CONFIRMED. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
(B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNDER DELIVERY ANOMALY. CUSTOMER WAS HAVING HIGH BLOOD GLUCOSE OF 19.8 MMOL/L FOR WHICH CUSTOMER HAD VISITED TO EMERGENCY ROOM AND TREATED WITH INSULIN PEN. CUSTOMERS CURRENT BLOOD GLUCOSE WAS 10 MMOL/L. CUSTOMER DECLINED TO TEST THE PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR FURTHER ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1780077 | MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1885 | HG4ZHK1 | 000000763000384258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |