630G INSULIN PUMP MMT-1715KL 630G Adverse Event — Malfunction (MDR 2032227-2020-111145)
630G INSULIN PUMP MMT-1715KL 630G Adverse Event — Malfunction (MDR 2032227-2020-111145) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: 630G INSULIN PUMP MMT-1715KL 630G; Generic name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND; Manufacturer: MEDTRONIC PUERTO RICO OPER
| Device | 630G INSULIN PUMP MMT-1715KL 630G |
|---|---|
| Generic name | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Report number | 2032227-2020-111145 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | Consumer |
| Narrative | THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. UPDATED H9: Z-0955-2020 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 T |
| Source | openFDA MAUDE (device adverse events) |
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