FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 10881376
·
Received November 21, 2020
Report
- Report Number
- 3013756811-2020-130042
- Event Type
- Malfunction
- Date Received
- November 21, 2020
- Date of Event
- November 2, 2020
- Report Date
- November 21, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007325
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
TANDEM QUALITY ENGINEER EVALUATED PUMP DATA AND CONCLUDED THE FOLLOWING: THERE IS NO EVIDENCE THAT THE PUMP EXPERIENCED A MALFUNCTION OR FAILURE.
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 AND EVALUATION IS PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP DELIVERED A BOLUS WITHOUT USER INPUT. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM 180-209 MG/DL. REVIEW OF THE PUMP DATA LOGS BY TANDEM TECHNICAL SUPPORT VERIFIED THE BOLUS WAS MANUALLY REQUESTED BY THE CUSTOMER. CUSTOMER MAINTAINED BELIEF THAT PUMP DELIVERED A BOLUS WITHOUT USER INPUT. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1346078 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000354 | 00853052007325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |