FDA Adverse Event
Malfunction
Summary report: N
T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 7454336
·
Received April 24, 2018
Report
- Report Number
- 3013756811-2018-13412
- Event Type
- Malfunction
- Date Received
- April 24, 2018
- Date of Event
- June 14, 2017
- Report Date
- April 24, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. BLOOD GLUCOSE RANGED FROM 100-250 MG/DL, REPORTEDLY, THE SUPPLIES WERE CHANGED TO ADDRESS THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297807 | T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | INFUSION SET: AUTOSOFT 90, INSULIN, NOVOLOG |