FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 11807365
·
Received May 11, 2021
Report
- Report Number
- 3013756811-2021-51500
- Event Type
- Malfunction
- Date Received
- May 11, 2021
- Date of Event
- April 22, 2021
- Report Date
- May 11, 2021
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613793
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT CARTRIDGE CHANGE ERRORS OCCURRED WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 192-200 MG/DL. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS AVAILABLE AS ALTERNATE INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705192 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000354 | 00850006613793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |