FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
MDR report key: 10384508
·
Received August 10, 2020
Report
- Report Number
- 3013756811-2020-82816
- Event Type
- Malfunction
- Date Received
- August 10, 2020
- Date of Event
- July 18, 2020
- Report Date
- August 10, 2020
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613205
- PMA / PMN Number
- DEN180058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, 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 AN OCCLUSION ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 200-379 MG/DL. DURING TROUBLESHOOTING, IT WAS DETERMINED THAT THE CARTRIDGE WAS THE CAUSE OF THE OCCLUSION. REPORTEDLY, THE CARTRIDGE WAS CHANGED TO ADDRESS THE ISSUE AND INSULIN DELIVERY WAS RESUMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 848182 | T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | M542970 | 00850006613205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | INSULIN: NOVOLOG / NOVORAPIDINFUSION SET: AUTOSOF |