FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 12217362
·
Received July 23, 2021
Report
- Report Number
- 3013756811-2021-81239
- Event Type
- Malfunction
- Date Received
- July 23, 2021
- Date of Event
- July 18, 2021
- Report Date
- July 23, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00850006613380
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES AND RESUMED INSULIN DELIVERY. SYSTEM CHECK WAS PERFORMED BY TANDEM TECHNICAL SUPPORT AND NO ISSUES WERE IDENTIFIED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS IN THE 162-173 MG/DL RANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1115298 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1002717 | 00850006613380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | INFUSION SET: AUTOSOFT XCINSULIN: NOVOLOG |