640G INSULIN PUMP MMT-1711K
Report
- Report Number
- 2032227-2018-22354
- Event Type
- Death
- Date Received
- September 4, 2018
- Date of Event
- July 21, 2018
- Report Date
- June 14, 2022
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- UDI-DI
- 00643169739468
- Removal / Correction Number
- 2032227-060322-002-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. Z-0958-2020. 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.
2032227-060322-002-C. 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. 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.
THE INFORMATION THAT PROVIDED WITH THE INITIAL REPORT WAS INCORRECT. THE CORRECT INFORMATION HAS BEEN INCLUDED WITH THIS REPORT.
(B)(4).
THE DEVICE DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. DEVICE PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST AND FORCE SENSOR TEST. UNABLE TO PERFORM THE DISPLACEMENT TEST, OCCLUSION TEST AND DELIVERY ACCURACY TEST DUE TO MISSING RETAINER. THE TEST P-CAP AND RESERVOIR WILL NOT LOCK IN PLACE IN THE RESERVOIR COMPARTMENT DUE TO MISSING RETAINER. DEVICE RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. UNABLE TO VERIFY DAMAGE TO THE ORIGINAL BATTERY CAP. DEVICE ALSO HAD CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE CORNER OF THE BELT CLIP RAIL, MISSING RESERVOIR TUBE O-RING, BROKEN RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, MISSING DISPLAY WINDOW COVER, SCRATCHED CASE, MISSING SERIAL NUMBER LABEL, FADED END CAP ADDRESS LABEL, SCRATCHED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON.
IT WAS REPORTED BY A NURSE THAT THE CUSTOMER PASSED AWAY IN AN UNKNOWN LOCATION. THE CAUSE OF DEATH WAS KETOACIDOSIS AND HEART STOPPAGE. THE CALLER DID NOT STATE WHETHER THE CUSTOMER HAD ANY OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. THE CALLER STATED THAT AFTER REVIEWING PUMP MEMORY, THERE WAS A 3 DAY PERIOD WHERE THE CUSTOMER HAD GIVEN THEMSELVES A LOT OF BOLUSES. THE CALLER REPORTED BATTERY CAP DAMAGE, PUMP PHYSICAL DAMAGE, AS WELL AS A DANGLING RETAINER RING, BUT WAS UNSURE IF THE PUMP DAMAGE HAPPENED BEFORE CUSTOMER WAS BEING TRANSPORTED TO THE HOSPITAL. THE CALLER WAS GOING TO CALL BACK WHEN THEY HAD MORE DETAILS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.
IT WAS REPORTED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. CUSTOMER USED DEXCOM SENSORS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
THE CUSTOMER'S DATE OF DEATH WAS (B)(6) 2018.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 682821 | 640G INSULIN PUMP MMT-1711K | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1711K | HG14V7D | 00643169739468 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | FRN- MODEL UNKNOWN¿RESERVOIR| FRN- MODEL UNKNOWN¿RESERVOIR |