FDA Adverse Event
Injury
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 4151916
·
Received October 6, 2014
Report
- Report Number
- 3007981285-2014-08781
- Event Type
- Injury
- Date Received
- October 6, 2014
- Date of Event
- July 10, 2014
- Report Date
- September 10, 2014
- Manufacturer
- TANDEM DIABETES CARE INC.
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FOLLOW UP WITH CUSTOMER ON (B)(6) 2014 INDICATED THAT THE CUSTOMER CHANGED OUT THE CARTRIDGE AND INFUSION SET AND NO ADDITIONAL OCCLUSION ALARMS OCCURRED. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE OCCLUSION ALARMS. REPORTEDLY, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 623085 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE INC. | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other | INFUSION SET: MEDTRONIC QUICKSET| INSULIN: HUMALOG |