FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 9440651
·
Received December 9, 2019
Report
- Report Number
- 3013756811-2019-88193
- Event Type
- Malfunction
- Date Received
- December 9, 2019
- Date of Event
- November 25, 2019
- Report Date
- December 9, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PER TANDEM¿S CARTRIDGE INSTRUCTIONS FOR USE: "REPLACE THE CARTRIDGE EVERY 48 HOURS IF USING HUMALOG; EVERY 72 HOURS IF USING NOVOLOG." 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 MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 200-398 MG/DL. ADDITIONALLY, THE PUMP SUPPLIES WERE IN USE FOR MORE THAN 3 DAYS WITH NOVOLOG INSULIN. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER REGARDING CARTRIDGE/INSULIN LABELING. REPORTEDLY, AIR WAS OBSERVED IN THE INFUSION SET TUBING. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1230516 | T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | TANDEM DIABETES CARE | 1000096 | 00853052007264 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |