FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 15551751
·
Received October 6, 2022
Report
- Report Number
- 3013756811-2022-112112
- Event Type
- Malfunction
- Date Received
- October 6, 2022
- Date of Event
- September 13, 2022
- Report Date
- November 17, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613793
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED. DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 132-207 MG/DL. THE CUSTOMER WILL CONTINUE TO USE THE PUMP FOR INSULIN THERAPY, HOWEVER, A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2888325 | 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 | 78 YR | Female |