FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 10289135
·
Received July 17, 2020
Report
- Report Number
- 3013756811-2020-72961
- Event Type
- Malfunction
- Date Received
- July 17, 2020
- Date of Event
- May 19, 2020
- Report Date
- July 17, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007325
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE T:SLIM X2 BASAL IQ USER GUIDE STATES: THE INFUSION SET SHOULD BE CHANGED EVERY 48-72 HOURS, PER GUIDANCE FROM THE CUSTOMER'S HEALTHCARE PROVIDER. ADDITIONALLY, CHANGE YOUR CARTRIDGE EVERY 48¿72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER. 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 DURING BASAL AND BOLUS DELIVERY. CUSTOMER CHANGED SUPPLIES TO ADDRESS OCCLUSION ALARMS. CUSTOMER REPORTED USING SUPPLIES FOR THREE DAYS. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT IS OFF-LABEL PER THE USER GUIDE. CUSTOMER REPORTED BLOOD GLUCOSE LEVEL RANGED FROM 200-265 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756515 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007325 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | INFUSION SET: TRUSTEELINSULIN: NOVOLOG |