FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 13515310
·
Received February 11, 2022
Report
- Report Number
- 3013756811-2022-10476
- Event Type
- Malfunction
- Date Received
- February 11, 2022
- Date of Event
- January 20, 2022
- Report Date
- February 11, 2022
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613762
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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. PER TANDEM USER GUIDE: ONLY USE U-100 HUMALOG OR U-100 NOVOLOG WITH YOUR PUMP. ONLY U-100 HUMALOG AND NOVOLOG HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE PUMP. USE OF INSULIN WITH LESSER OR GREATER CONCENTRATION CAN RESULT IN UNDER DELIVERY OR OVER DELIVERY OF INSULIN. THIS CAN CAUSE HYPOGLYCEMIA (LOW BG) OR HYPERGLYCEMIA (HIGH BG) EVENTS.
Description of Event or Problem · 0
IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. REPORTEDLY, CUSTOMER IS USING ADMELOG INSULIN. CUSTOMER CLEARED THE ALARM AND RESUMED INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 232-240 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 111143 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1002717 | 00850006613762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | INSULIN: ADMELOGINFUSION SET: AUTOSOFT XC |