FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 14828838
·
Received June 27, 2022
Report
- Report Number
- 3013756811-2022-64409
- Event Type
- Malfunction
- Date Received
- June 27, 2022
- Date of Event
- May 31, 2022
- Report Date
- June 7, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT MULTIPLE OCCLUSION ALARMS OCCURRED. A SYSTEM CHECK WAS PERFORMED, AND THE PUMP PERFORMED AS INTENDED. CUSTOMER SUCCESSFULLY RESUMED INSULIN DELIVERIES AFTER THE SYSTEM CHECK. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 153-181 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1072243 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Male | INFUSION: AUTOSOFT 90 |