FDA Adverse Event
Injury
Summary report: N
T:SLIM X2 TANDEM INSULIN PUMP
MDR report key: 22873433
·
Received August 22, 2025
Report
- Report Number
- MW5175117
- Event Type
- Injury
- Date Received
- August 22, 2025
- Date of Event
- August 7, 2025
- Report Date
- September 17, 2025
- Manufacturer
- TANDEM DIABETES CARE, INC.
- Product Code
- QFG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
MY DEXCOM G7 HAD A "BRIEF SENSOR ISSUE" THAT LASTED SEVERAL HOURS. MY TANDEM INSULIN PUMP WAS GETTING FALSE READINGS THAT LEAD TO INSULIN STACKING, WHICH CAUSE MY BLOOD SUGAR TO CRASH SEVERELY AND I ALMOST PASSED OUT. I HAD TO CLOCK OUT OF MY REMOTE JOB EARLY AND GET A NOTE FROM MY ENDOCRINOLOGIST TO EXCUSE MY LEAVING EARLY. PATIENT CODES: 1912. DEVICE CODES: 1535, 3023, 2339. REFERENCE REPORT #MW5175116.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED FOR MW5175117 ON SEPTEMBER 17, 2025 TO UPDATE PROCODE TO QFG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2871939 | T:SLIM X2 TANDEM INSULIN PUMP | ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP | QFG | TANDEM DIABETES CARE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Female | Disability| L | BABY ASPIRIN.| GABAPENTIN.| HUMALOG.| LAMICTAL.| LATUDA.| MELATONIN.| PLAQUENIL.| TESTOSTERONE.| ZOFRAN. |