FDA Adverse Event
Injury
Summary report: N
INSET
MDR report key: 24753276
·
Received April 1, 2026
Report
- Report Number
- 3003442380-2026-89865
- Event Type
- Injury
- Date Received
- April 1, 2026
- Date of Event
- February 18, 2026
- Report Date
- March 5, 2026
- Manufacturer
- TANDEM
- Product Code
- FPA
- UDI-DI
- 05705244016682
- PMA / PMN Number
- K032854
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL 2 OF 3. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 8021545, MANUFACTURING SITE: 3003442380.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT FACED THREE INFUSION SETS BENT CANNULA EVENTS ON 08-FEB-2026, 18-FEB-2026 AND 26-FEB-2026 AT UPPER BUTTOCKS AND ABDOMEN INSERTION SITE. BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF THE EVENT AND PATIENT TOOK CORRECTION BOLUS VIA PUMP TO RESOLVE THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 818902 | INSET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | TANDEM | 1001682 | 6014874 | 05705244016682 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Female |