FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G5 SYSTEM
MDR report key: 8478444
·
Received April 3, 2019
Report
- Report Number
- 3013756811-2019-16691
- Event Type
- Malfunction
- Date Received
- April 3, 2019
- Date of Event
- March 8, 2019
- Report Date
- April 3, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 00853052007257
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP DECLARED MULTIPLE, INTERMITTENT TEMPERATURE ALARMS WHILE THE CUSTOMER WAS CHARGING THE PUMP. REPORTEDLY, THE PUMP WAS NOT EXPOSED TO EXTREME TEMPERATURES AND THE ALARMS REPEATED WHILE THE PUMP WAS CHARGING. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 212-229 MG/DL. REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP AND HAD MANUAL INJECTIONS FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270313 | T:SLIM G5 SYSTEM | CONTINUOUS GLUCOSE MONITOR | OYC | TANDEM DIABETES CARE | 1000096 | 00853052007257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |