FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 19124940
·
Received April 17, 2024
Report
- Report Number
- 3013756811-2024-67159
- Event Type
- Injury
- Date Received
- April 17, 2024
- Date of Event
- March 25, 2024
- Report Date
- April 17, 2024
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 243-500'S MG/DL, WITH HIGH KETONES. ELEVATED BLOOD GLUCOSE LEVELS WERE ADDRESSED BY MANUAL INSULIN INJECTION. ULTIMATELY, THE CUSTOMER REVERTED TO AN ALTERNATE FORM OF INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1856580 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | W1220106 | 00850006613762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Male | INFUSION SET: AUTOSOFT XC.INSULIN: HUMALOG. |