N
Patient 1
(B)(4). UNIT RECEIVED WITH MISSING RETAINER RING AND RESERVOIR TUBE LIP O-RING. UNABLE TO PERFORM DISPLACEMENT TEST AND P-CAP OR RESERVOIR WILL NOT LOCK PROPERLY DUE TO MISSING RETAINER.
MAUDE MDR 9392212
- MDR report key
- 9392212
- Report number
- 2032227-2019-125368
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-09-02
- Date received
- 2019-11-30
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- GERWIN DE GRAAFF
- Address
- CEIBA NORTE IND. PARK #50 ROAD JUNCOS 00777
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-1782K 670G V4.11 MM | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | MEDTRONIC PUERTO RICO OPERATIONS CO. | OZP | MMT-1782K | MMT-1782K | HG2Y0QF | R | R | |||
| 1404738 | PUMP MMT-1782K 670G V4.11 MM | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | MEDTRONIC PUERTO RICO OPERATIONS CO. | OZP | MMT-1782K | MMT-1782K | HG2Y0QF | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-11-30 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THEIR RESERVOIR COMPARTMENT WAS DAMAGED. THE CUSTOMER?S BLOOD GLUCOSE LEVEL WAS 7.2 MMOL/L. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND NOTICED THE RESERVOIR LOCK IN PLACE. ADVISED THE PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
N
Patient 0
THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. UPDATED H9: Z-0956-2020 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.