FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 10338761
·
Received July 29, 2020
Report
- Report Number
- 3013756811-2020-80044
- Event Type
- Malfunction
- Date Received
- July 29, 2020
- Date of Event
- July 5, 2020
- Report Date
- July 29, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00085006613373
- PMA / PMN Number
- P180008
- Product Problem
- 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 PATIENT LINE SEPARATED FROM THE CARTRIDGE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 151-200 MG/DL. CUSTOMER ACKNOWLEDGED DAMAGE WAS RELATED TO USER ERROR AND WAS ABLE TO LOAD A NEW CARTRIDGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 803586 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 | 00085006613373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | INSULIN: NOVOLOG / NOVORAPIDINFUSION SET: TRUSTEE |