FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 13966023
·
Received March 31, 2022
Report
- Report Number
- 3013756811-2022-33122
- Event Type
- Injury
- Date Received
- March 31, 2022
- Date of Event
- March 16, 2022
- Report Date
- March 16, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613205
- PMA / PMN Number
- K201214
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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
REPORTEDLY, THERE WAS AN O-RING ON THE PNEUMATIC TAP. CUSTOMER REMOVED THE O-RING. CUSTOMER RELOADED CARTRIDGE AND RECEIVED A CARTRIDGE CHANGE ERROR. CUSTOMER RELOADED SECOND CARTRIDGE AND WAS ABLE TO RESUME INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 192-510 MG/DL. CUSTOMER ADMINISTERED A MANUAL CORRECTION INJECTION OF INSULIN TO ADDRESS HIGH BLOOD GLUCOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1391512 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | W0047490 | 00850006613205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | Other |