FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 7860529
·
Received September 10, 2018
Report
- Report Number
- 3013756811-2018-30902
- Event Type
- Malfunction
- Date Received
- September 10, 2018
- Date of Event
- August 19, 2018
- Report Date
- September 10, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007257532398
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE, INTERMITTENT MALFUNCTION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM (160-500) MG/DL. A CORRECTION BOLUS VIA MANUAL INJECTIONS WAS ADMINISTERED. REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 700284 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007257532398 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |