FDA Adverse Event
Malfunction
Summary report: N
T:SLIM G4 SYSTEM
MDR report key: 10207264
·
Received June 29, 2020
Report
- Report Number
- 3013756811-2020-66162
- Event Type
- Malfunction
- Date Received
- June 29, 2020
- Date of Event
- June 5, 2020
- Report Date
- June 29, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- OYC
- UDI-DI
- 852162004439
- PMA / PMN Number
- P140015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
B3.
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 OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED OUT PUMP SUPPLIES TO ADDRESS THE ALARMS. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 200-495 MG/DL. CUSTOMER ADMINISTERED AN INSULIN BOLUS VIA PUMP TO ADDRESS ELEVATED BLOOD GLUCOSE LEVEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673239 | T:SLIM G4 SYSTEM | INSULIN PUMP | OYC | TANDEM DIABETES CARE | 4628-003 | 852162004439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | INSULIN: NOVOLOG: INFUSION SET: TRUSTEEL |