FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 13636229
·
Received March 1, 2022
Report
- Report Number
- 3013756811-2022-16968
- Event Type
- Injury
- Date Received
- March 1, 2022
- Date of Event
- February 6, 2022
- Report Date
- February 6, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613793
- PMA / PMN Number
- K201214
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
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 · 0
IT WAS REPORTED THAT THE WAKE BUTTON WAS NOT WORKING. CUSTOMER PRESSED THE WAKE BUTTON WITH MORE FORCE AND THE WAKE BUTTON PERFORMED AS INTENDED. ADDITIONALLY, IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. CUSTOMERS BLOOD GLUCOSE WAS 140-600 MG/DL. ELEVATED BG WAS ADDRESS BY CORRECTION BOLUS VIA PUMP. CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1390041 | 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 | 67 YR | Female | Other |