FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2, BASAL-IQ, MMOL/L
MDR report key: 11388312
·
Received February 26, 2021
Report
- Report Number
- 3013756811-2021-21556
- Event Type
- Malfunction
- Date Received
- February 26, 2021
- Date of Event
- January 30, 2021
- Report Date
- February 26, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00850006613021
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CARTRIDGE SEPTUM WAS LEAKING INSULIN DURING THE LOADING PROCESS. CUSTOMER CHANGED THE CARTRIDGE TO RESOLVE THE ISSUE. CUSTOMER'S BLOOD GLUCOSE WAS 180-225 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283092 | T:SLIM X2, BASAL-IQ, MMOL/L | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 | 00850006613021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |