FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 10655674
·
Received October 9, 2020
Report
- Report Number
- 3013756811-2020-110664
- Event Type
- Malfunction
- Date Received
- October 9, 2020
- Date of Event
- September 19, 2020
- Report Date
- October 9, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 852162004439
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
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 INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CLEARED THE ALARM, OR CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE AND RESUMED INSULIN DELIVERY. DURING SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT, THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE CUSTOMER DECLINED TO REMOVE THE INFUSION SET CANNULA FROM THE INFUSION SITE. CUSTOMER'S BLOOD GLUCOSE WAS 100-124 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1119685 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 | 852162004439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | INFUSION SET: AUTOSOFT 90 |