PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS
Report
- Report Number
- 2032227-2023-157292
- Event Type
- Death
- Date Received
- February 13, 2023
- Date of Event
- September 30, 2021
- Report Date
- February 12, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- UDI-DI
- 000000643169513914
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 003
Narratives
THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION. (B)(4). S/W 3.0B. THE CUSTOMER PASSED AWAY ON (B)(6) 2021. PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DAT AT 0.0875 INCHES. THE STOP (IDLE) CURRENT AND RUN CURRENT MEASUREMENT TESTS ARE WITHIN SPECIFICATION. PUMP ALSO PASSED SELF TEST, OFF NO POWER ALARM TEST AND A21 ERROR TEST. HISTORY DOWNLOAD WAS SUCCESSFUL USING THDS AND CARELINK UPLOAD WAS SUCCESSFUL. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HOWEVER, A CRACKED RESERVOIR TUBE LIP WAS NOTED DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, A SMALL CRACK ON THE DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, BROKEN BATTERY TUBE THREADS, SCRATCHED RESERVOIR TUBE WINDOW. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. PLEASE SEE BELOW THE DAILY INSULIN TOTAL SURROUNDING THE EVENT DATE 30-SEP-2021 LISTED ON SMARTSOLVE AND THE DAYS PRIOR TO THE EVENT DATE. (B)(6) 2021 00:00:00 DAILY INSULIN TOTAL = 22.900U, (B)(6) 2021 00:00:00 DAILY INSULIN TOTAL = 22.900U, (B)(6) 2021 00:00:00 DAILY INSULIN TOTAL = 22.500U, (B)(6) 2021 00:00:00 DAILY INSULIN TOTAL = 19.475U, (B)(6) 2021 00:00:00 DAILY INSULIN TOTAL = 20.200U, (B)(6) 2021 00:00:00 DAILY INSULIN TOTAL = 18.300U, (B)(6) 2021 00:00:00 DAILY INSULIN TOTAL = 19.800U. THE PUMP PASSED THE FUNCTIONAL TESTING. A CRACKED RESERVOIR TUBE LIP WAS CONFIRMED. 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.
MEDTRONIC RECEIVED INFORMATION THAT HARM REPORTED, WITH NO ALLEGATION OCCURRED. THERE WAS AN ALLEGATION OF DEATH AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 797716 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723LNAS | A5723LNASJ | 000000643169513914 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | Death | FRN-MMT-322-RSVR, INFST MMT-387 |