FDA Adverse Event
Injury
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 6187424
·
Received December 19, 2016
Report
- Report Number
- 3007981285-2016-24989
- Event Type
- Injury
- Date Received
- December 19, 2016
- Date of Event
- November 28, 2016
- Report Date
- November 30, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING MULTIPLE INCIDENTS OF ELEVATED BLOOD GLUCOSE (BG) LEVELS RANGING BETWEEN 250-338 MG/DL WITH MILD KETONES PRESENT. THE CUSTOMER WOULD DELIVER BOLUSES TO STABILIZE BG LEVELS. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT (CTS), A SYSTEM CHECK WAS PERFORMED AND INDICATED THAT THE PUMP WAS FUNCTIONING AS INTENDED. A RECOMMENDATION WAS MADE FOR THE CUSTOMER TO CONTACT THE HEALTHCARE PROVIDER TO DISCUSS FACTORS THAT MAY AFFECT BG LEVEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837987 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 | M018621 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Other | INFUSION SET: INSET, INSULIN: NOVOLOG |