FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 8175889
·
Received December 18, 2018
Report
- Report Number
- 3013756811-2018-46942
- Event Type
- Malfunction
- Date Received
- December 18, 2018
- Date of Event
- December 13, 2018
- Report Date
- December 18, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004781
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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 MULTIPLE MALFUNCTION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 201-350 MG/DL. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1013528 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 1000096 | 00852162004781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | INFUSION SET: AUTOSOFT 30, INSULIN: HUMALOG |