MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for T:FLEX INSULIN DELIVERY SYSTEM 004628-005 005365 manufactured by Tandem Diabetes Care.
[186751848]
The device has been received for evaluation; however, device evaluation is not yet complete. A supplemental report will be filed upon completion of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[186751849]
It was reported that the insulin gauge was inaccurate. Customer? S blood glucose was 257 mg/dl. Reportedly, the customer will use the current pump until replacement pump arrives.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013756811-2020-33105 |
| MDR Report Key | 9907760 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2016-10-01 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICK TRIER |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584011451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T:FLEX INSULIN DELIVERY SYSTEM |
| Generic Name | INFUSION PUMP |
| Product Code | LZG |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-25 |
| Model Number | 004628-005 |
| Catalog Number | 005365 |
| Lot Number | M225424 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TANDEM DIABETES CARE |
| Manufacturer Address | 11075 ROSELLE STREET SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |