FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
MDR report key: 8174830
·
Received December 18, 2018
Report
- Report Number
- 3013756811-2018-47070
- Event Type
- Malfunction
- Date Received
- December 18, 2018
- Date of Event
- December 14, 2018
- Report Date
- December 18, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OZO
- UDI-DI
- 00853052007264
- PMA / PMN Number
- P180008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP USER GUIDE STATES DO NOT REUSE CARTRIDGES OR USE CARTRIDGES OTHER THAN THOSE MANUFACTURED BY TANDEM DIABETES CARE, INC. USE OF CARTRIDGES NOT MANUFACTURED BY TANDEM DIABETES CARE, INC. OR REUSE OF CARTRIDGES MAY RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. THIS CAN CAUSE VERY LOW OR VERY HIGH BLOOD GLUCOSE. 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 A MINIMUM FILL NOTIFICATION OCCURRED AFTER FILLING A RE-USED CARTRIDGE WITH 100 UNITS OF INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 123 MG/DL. REPORTEDLY, CUSTOMER DECLINED A FOLLOW UP CALL FROM TANDEM TECHNICAL SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1012722 | 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 | 72 YR |