FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 7887579
·
Received September 18, 2018
Report
- Report Number
- 3013756811-2018-32731
- Event Type
- Malfunction
- Date Received
- September 18, 2018
- Date of Event
- August 16, 2018
- Report Date
- September 18, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 85216200443990470944
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE, INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY, A TEMPERATURE CHANGE HAD OCCURRED TO THE PUMP PRIOR TO THE OCCLUSION ALARM DECLARING. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 112-185 MG/DL. THE SUPPLIES WERE CHANGED TO ADDRESS THE EVENT AND INSULIN DELIVERY WAS RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726143 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 | 85216200443990470944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |