FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 10091759
·
Received May 27, 2020
Report
- Report Number
- 3013756811-2020-56206
- Event Type
- Malfunction
- Date Received
- May 27, 2020
- Date of Event
- May 18, 2020
- Report Date
- May 27, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007325
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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 CLEARED THE ALARM AND RESUMED INSULIN DELIVERY. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND NO ISSUES WERE IDENTIFIED. NO ISSUES WERE FOUND DURING SYSTEM CHECK. CUSTOMERS BLOOD GLUCOSE WAS 200-315 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 554628 | 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 | 19 YR | INFUSION SET: AUTOSOFT 90, INSULIN: HUMALOG |