FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 8925780
·
Received August 23, 2019
Report
- Report Number
- 3013756811-2019-51098
- Event Type
- Injury
- Date Received
- August 23, 2019
- Date of Event
- July 31, 2019
- Report Date
- August 23, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007301
- PMA / PMN Number
- P180008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 43 MG/DL. REPORTEDLY, CUSTOMER DID NOT EAT A SNACK PRIOR TO GOING TO BED AND IS A "BRITTLE" DIABETIC. CUSTOMER CONSUMED NUTS AND ORANGE JUICE TO ADDRESS THE LOW BG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 719635 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other |