t:slim X2 Insulin Pump with Control-IQ+ Technology · Alternate Controller Enabled Insulin Infusion Pump
Tandem Diabetes Care · Incorrect Measurement
- Manufacturer contact state
- CA
- Manufacturer link flag
- Y
- Manufacturer contact address 1
- 12400 High Bluff Drive
- Manufacturer contact pcity
- +1(858)2
- Event type
- Malfunction
- Report number
- 3013756811-2026-177588
- Product problem flag
- Y
- Date received
- 20260930
- PMA pmn number
- K250792
- Date of event
- 20260920
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 92130
- Manufacturer contact plocal
- +1(858)224-6281
- Noe summarized
- 1
- Manufacturer contact l name
- Connell
- Reporter country code
- US
- Date added
- 20260930
- Manufacturer contact f name
- John
- Device date of manufacturer
- 20250408
- Previous use code
- R
- Reporter state code
- IN
- Mfr report type
- Thirty-Day
- Manufacturer contact country
- US
- Date changed
- 20260930
- Health professional
- N
- Summary report flag
- N
- Date report
- 20260929
- Manufacturer contact city
- San Diego
- MDR report key
- 50941433
- Date manufacturer received
- 20260920
- Report source code
- Manufacturer report
- Adverse event flag
- N
- Single use flag
- N
- Manufacturer contact postal code
- 92130
- Type of report
- Initial submission
- Source type
- Consumer
- Device
- Device sequence number
- 443245
- Date received
- 20260930
- Brand name
- t:slim X2 Insulin Pump with Control-IQ+ Technology
- Generic name
- Alternate Controller Enabled Insulin Infusion Pump
- Manufacturer d name
- Tandem Diabetes Care
- Manufacturer d address 1
- 12400 High Bluff Drive
- Manufacturer d city
- San Diego
- Manufacturer d state
- CA
- Manufacturer d zip code
- 92130
- Manufacturer d country
- US
- Manufacturer d postal code
- 92130
- Device operator
- LAY USER/PATIENT
- Model number
- 1002717
- Catalog number
- 1014070
- Device availability
- No
- Device report product code
- QFG
- Device evaluated by manufacturer
- N
- Combination product flag
- N
- UDI di
- 00389152407012
- UDI public
- (01)00389152407012(22)1016546(11)250408
- Harmonized identifiers (openFDA)
- Device name
- Alternate Controller Enabled Insulin Infusion Pump
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 880.5730
- Device class
- 2
- Product problems
- Incorrect Measurement
- Patient
- Patient sequence number
- 1
- Patient problems
- No Clinical Signs, Symptoms or Conditions