QUICK-SET® PARADIGM® Adverse Event — Malfunction (MDR 3003442380-2020-00256)
QUICK-SET® PARADIGM® Adverse Event — Malfunction (MDR 3003442380-2020-00256) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: QUICK-SET® PARADIGM®; Generic name: QUICK-SET 110/9 PCC; Report number: 3003442380-2020-00256.
| Device | QUICK-SET® PARADIGM® |
|---|---|
| Generic name | QUICK-SET 110/9 PCC |
| Report number | 3003442380-2020-00256 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR |
| Narrative | UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING GOT DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN CAME OUT OF THE TUBING ABOUT FOUR HOURS, AFTER THE SET WAS CHANGED. THIS ISSUE OCCURRED WITH TWO SETS. NO FURTHER INFORMATION AVAILABLE. |
| Source | openFDA MAUDE (device adverse events) |
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