FDA Adverse Event
Malfunction
Summary report: N
T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 9359227
·
Received November 21, 2019
Report
- Report Number
- 3013756811-2019-81482
- Event Type
- Malfunction
- Date Received
- November 21, 2019
- Date of Event
- November 6, 2019
- Report Date
- November 21, 2019
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- UDI-DI
- 00852162004361
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, 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 MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 183-316 MG/DL. A SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND THE OCCLUSION ALARMS WERE VERIFIED. REPORTEDLY, CUSTOMER CHANGED THE PUMP SUPPLIES OR SIMPLY CLEARED THE ALARM AND RESUMED INSULIN DELIVERY TO ADDRESS THE ISSUE. REPORTEDLY, A TEMPERATURE CHANGE HAD OCCURRED TO THE PUMP PRIOR TO THE OCCLUSION ALARMS DECLARING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1149612 | T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 | 00852162004361 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |