FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 14735417
·
Received June 17, 2022
Report
- Report Number
- 3013756811-2022-60133
- Event Type
- Malfunction
- Date Received
- June 17, 2022
- Date of Event
- May 27, 2022
- Report Date
- May 27, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613779
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. ADDITIONALLY, IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 142-180 MG/DL. CUSTOMER DECLINED TO FURTHER TROUBLESHOOT WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203362 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male |