FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 9158021
·
Received October 4, 2019
Report
- Report Number
- 3013756811-2019-63775
- Event Type
- Injury
- Date Received
- October 4, 2019
- Date of Event
- September 10, 2019
- Report Date
- October 4, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) OF 40 MG/DL. REPORTEDLY, THE CUSTOMER REQUESTED TOO MUCH INSULIN BE DELIVERED THROUGH A BOLUS. CUSTOMER DRANK JUICE, ATE FRUIT SNACKS, AND ADMINISTERED GLUCOSE SHOTS TO TREAT BG. REVIEW OF THE PUMP DATA LOGS BY TANDEM TECHNICAL SUPPORT VERIFIED THAT THE CUSTOMER HAD ENTERED 20 MG/DL INTO THE BG FIELD INSTEAD OF 20 GRAMS INTO THE CARBOHYDRATES FIELD OF THE BOLUS MENU AS INTENDED. RECOMMENDATION WAS MADE TO CONSULT WITH HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 950256 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Other |