FDA Adverse Event
Injury
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 5787287
·
Received July 12, 2016
Report
- Report Number
- 3007981285-2016-90669
- Event Type
- Injury
- Date Received
- July 12, 2016
- Date of Event
- June 20, 2016
- Report Date
- June 20, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
ON 06/23/2016: TANDEM TECHNICAL SUPPORT MADE MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER, HOWEVER NO FURTHER INFORMATION WAS PROVIDED. 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'S FILL ESTIMATE WAS INACCURATE. WHILE CONTACTING TANDEM TECHNICAL SUPPORT, THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE 203-490 MG/DL AND HAD DELIVERED A CORRECTION BOLUS TO ADDRESS BG LEVEL. THE CUSTOMER HAD LOADED A NEW CARTRIDGE. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441967 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other | INFUSION SET: INSET INSULIN: HUMALOG |