FDA Adverse Event
Injury
Summary report: N
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 5498755
·
Received March 14, 2016
Report
- Report Number
- 3007981285-2016-73005
- Event Type
- Injury
- Date Received
- March 14, 2016
- Date of Event
- February 17, 2016
- Report Date
- March 2, 2016
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS AN AIR GAP IN THE PATIENT LINE. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS ELEVATED AND WAS BETWEEN 250-350 MG/DL. THE HIGH BG WAS CORRECTED BY DELIVERING A BOLUS. CUSTOMER WAS ABLE TO SUCCESSFULLY REMOVE AIR BUBBLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155898 | TANDEM T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other | INSULIN: HUMALOG, INFUSION SET: CONTACT DETACH |