FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)
MDR report key: 20523952
·
Received October 24, 2024
Report
- Report Number
- 3013756811-2024-198893
- Event Type
- Malfunction
- Date Received
- October 24, 2024
- Date of Event
- October 2, 2024
- Report Date
- October 24, 2024
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152000107
- PMA / PMN Number
- K203234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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. CHANGE YOUR CARTRIDGE EVERY 48¿72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER. DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED THE PUMP SUPPLIES TO ADDRESS THE ISSUE. REPORTEDLY, THE CUSTOMER IS PRE-FILLING CARTRIDGES. TANDEM CLINICAL SUPPORT INFORMED CUSTOMER THAT PREFILLING CARTRIDGES IS OFF LABEL PER THE USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 210-222 MG/DL. ULTIMATELY, THE CUSTOMER REVERTED TO AN ALTERNATE FORM OF INSULIN THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1715196 | T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000354 | 00389152000107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female | INFUSION SET: AUTOSOFT XC |