FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 16444625
·
Received February 27, 2023
Report
- Report Number
- 3013756811-2023-27295
- Event Type
- Malfunction
- Date Received
- February 27, 2023
- Date of Event
- February 4, 2023
- Report Date
- February 27, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613793
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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 ALTITUDE ALARMS OCCURRED WHILE THE CUSTOMER WAS NOT OUTSIDE OF THE LABELED OPERATING ALTITUDE RANGE. REPORTEDLY, AN OBSTRUCTION WAS BLOCKING THE SPEAKER HOLES. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 250-337 MG/DL. AFTER REMOVING THE OBSTRUCTION FROM THE SPEAKER HOLES, THE ALARM CLEARED AND CUSTOMER ULTIMATELY CLEARED ALARM AND CUSTOMER CONTINUED USING PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 800428 | 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 | 63 YR | Female | INSULIN: NOVOLOG / NOVORAPID |