ACCU-CHEK FLEXLINK INFUSION SET Adverse Event — Malfunction (MDR 3011393376-2020-01541)
ACCU-CHEK FLEXLINK INFUSION SET Adverse Event — Malfunction (MDR 3011393376-2020-01541) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ACCU-CHEK FLEXLINK INFUSION SET; Generic name: SUBCUTANEOUS INFUSION SET; Manufacturer: ROCHE DIABETES CARE, INC..
| Device | ACCU-CHEK FLEXLINK INFUSION SET |
|---|---|
| Generic name | SUBCUTANEOUS INFUSION SET |
| Manufacturer | ROCHE DIABETES CARE, INC. |
| Report number | 3011393376-2020-01541 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. |
| Source | openFDA MAUDE (device adverse events) |
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