FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 7068415
·
Received November 29, 2017
Report
- Report Number
- 3007981285-2017-35568
- Event Type
- Malfunction
- Date Received
- November 29, 2017
- Date of Event
- November 10, 2017
- Report Date
- November 29, 2017
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
AN ADDITIONAL LOT NUMBER WAS REPORTED (LOT # M020465). 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 THE CUSTOMER RECEIVED AN INACCURATE FILL ESTIMATE. REPORTEDLY, THE CARTRIDGE WAS FILLED WITH 200 UNITS OF INSULIN, AND THE INSULIN GAUGE DISPLAYED 0 UNITS, AFTER DELIVERING APPROXIMATELY 80 UNITS. THE CUSTOMER LOADED A NEW CARTRIDGE SUCCESSFULLY AND RECEIVED AN ACCURATE FILL ESTIMATE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 273 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 847826 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | M019996 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |