MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for SURE-T? PARADIGM? MMT-864 manufactured by .
[186202036]
Unomedical reference number (b)(4). Event occurred in the united sates. The patient reported that the infusion set's tubing came out of the connector to the short section of the infusion as he was not getting insulin delivery at all. Therefore, when he inspected the infusion set, he noticed that the tubing had no glue and there was no connector. Patient's blood glucose level was in the range of 480-490 mg/dl at the time of incident and ketone level was normal. On the day of this report ((b)(6) 2020), he already changed the infusion set and his blood glucose level was coming down. No further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003442380-2020-00226 |
| MDR Report Key | 9902409 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | AAHOLMVEJ 1-3 OSTED |
| Manufacturer City | LEJRE, 4320 |
| Manufacturer Country | DA |
| Manufacturer Postal | 4320 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURE-T? PARADIGM? |
| Generic Name | CONTACT DETACH G29 60/6 PCC |
| Product Code | FPA |
| Date Received | 2020-03-31 |
| Model Number | MMT-864 |
| Lot Number | 5285757 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |