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:SLIM G5 SYSTEM 1000096 1000911 manufactured by Tandem Diabetes Care.
[186520260]
The device is expected to be returned; however, the device has not yet been received. A supplemental report will be submitted if the device is received.
Patient Sequence No: 1, Text Type: N, H10
[186520261]
It was reported that the insulin gauge was inaccurate. Subsequently, the customer received a cartridge alarm (alarm 1). Additionally, a minimum fill notification occurred after reloaded the cartridge with 180 units of insulin.? Reportedly, a new cartridge was filled and loaded successfully. Customer's blood glucose was 157 mg/dl.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3013756811-2020-30377 |
MDR Report Key | 9908417 |
Report Source | CONSUMER |
Date Received | 2020-03-31 |
Date of Report | 2020-03-31 |
Date of Event | 2020-03-10 |
Date Mfgr Received | 2020-03-10 |
Device Manufacturer Date | 2018-09-01 |
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:SLIM G5 SYSTEM |
Generic Name | CONTINUOUS GLUCOSE MONITOR |
Product Code | OYC |
Date Received | 2020-03-31 |
Model Number | 1000096 |
Catalog Number | 1000911 |
Operator | LAY USER/PATIENT |
Device Availability | Y |
Device Eval'ed by Mfgr | R |
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 |