FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 16523257
·
Received March 10, 2023
Report
- Report Number
- 3013756811-2023-35877
- Event Type
- Malfunction
- Date Received
- March 10, 2023
- Date of Event
- February 19, 2023
- Report Date
- March 10, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00850006613793
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED THE ALTITUDE OPERATING RANGE. THE CUSTOMER'S BLOOD GLUCOSE RANGED BETWEEN 170-250 MG/DL. REPORTEDLY, CUSTOMER CLEANED THE SPEAKER HOLES AND ULTIMATELY CLEARED ALARM AND CUSTOMER CONTINUED USING PUMP FOR INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1055086 | 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 | 13 YR | Male |