FDA Adverse Event
Malfunction
Summary report: N
T:SLIM INSULIN DELIVERY SYSTEM
MDR report key: 7614792
·
Received June 19, 2018
Report
- Report Number
- 3013756811-2018-20410
- Event Type
- Malfunction
- Date Received
- June 19, 2018
- Date of Event
- May 29, 2018
- Report Date
- June 19, 2018
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- LZG
- PMA / PMN Number
- K111210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 122-248 MG/DL. DURING TROUBLESHOOTING, A TEST BOLUS WAS DELIVERED AND INSULIN WAS OBSERVED DRIPPING OUT OF THE INFUSION SET TUBING AS EXPECTED. REPORTEDLY, THE SUPPLIES WERE CHANGED TO ADDRESS THE EVENT AND INSULIN DELIVERY WAS RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 459005 | T:SLIM INSULIN DELIVERY SYSTEM | INSULIN PUMP | LZG | TANDEM DIABETES CARE | 004628 | M021582 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |