FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP
MDR report key: 7367826
·
Received March 23, 2018
Report
- Report Number
- 3013756811-2018-09016
- Event Type
- Injury
- Date Received
- March 23, 2018
- Date of Event
- March 3, 2018
- Report Date
- March 23, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
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 MULTIPLE, INTERMITTENT ALTITUDE ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER WAS UNABLE TO CLEAR THE MOST RECENTLY RECEIVED ALTITUDE ALARM. BLOOD GLUCOSE (BG) LEVELS RANGED BETWEEN 180-579 MG/DL AND A MANUAL INJECTION WAS ADMINISTERED TO CORRECT. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 209221 | T:SLIM X2 INSULIN PUMP | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 1000096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other |