FDA Adverse Event
Injury
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 4162957
·
Received October 8, 2014
Report
- Report Number
- 3007981285-2014-09264
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- September 16, 2014
- Report Date
- September 16, 2014
- Manufacturer
- TANDEM DIABETES CARE INC.
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FOLLOW UP ON (B)(4) 2014 INDICATED THAT THE CUSTOMER CHANGED THE CARTRIDGE, INFUSION SET TUBING/SITE, AND NO FURTHER OCCLUSIONS ALARMS OCCURRED. THE PRODUCT HAS NOT BEEN 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 THE CUSTOMER RECEIVED MULTIPLE OCCLUSION ALARMS DURING BOLUS DELIVERY. REPORTEDLY, THE ALARMS WERE CLEARED AND BOLUS WAS DELIVERED WITHOUT CHANGING INFUSION SET OR CARTRIDGE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED (HIGH).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631517 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE INC. | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Other | INSULIN: HUMALOG |