TWIIST AUTOMATED INSULIN DELIVERY SYSTEM
Report
- Report Number
- 3016798778-2026-00166
- Event Type
- Injury
- Date Received
- May 29, 2026
- Report Date
- May 29, 2026
- Manufacturer
- MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
- Product Code
- QFG
- UDI-DI
- 00850017421400
- PMA / PMN Number
- K250930
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ON (B)(6) 2026, IT WAS REPORTED THAT THE USER EXPERIENCED DIABETIC KETOACIDOSIS (DKA) OVER THE PREVIOUS WEEKEND (25-APR/26-APR); HOWEVER, THE SPECIFIC DATE OF THE EVENT WAS NOT PROVIDED. THEREFORE, THE EVENT DATE (B3) IS NOT PROVIDED IN THIS REPORT. BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE TWIST AUTOMATED INSULIN DELIVERY (AID) SYSTEM AND THE PATIENT'S DKA COULD NOT BE DETERMINED. INVESTIGATION INTO THE REPORTED EVENT REMAINS ONGOING AND A SUPPLEMENTAL REPORT WILL BE FILED ONCE RESULTS ARE AVAILABLE. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR FURTHER INVESTIGATION.
AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY SEQUEL MED TECH, LLC ON 01-MAY-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 02-MAY-2026. IT WAS REPORTED THAT WHILE THE USER WAS TRAVELING IN GERMANY, THEY EXPERIENCED DIABETIC KETOACIDOSIS AND PRESENTED TO THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED. THE USER REMAINS ONGOING ON THEIR TWIST PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592001 | TWIIST AUTOMATED INSULIN DELIVERY SYSTEM | INFUSION PUMP | QFG | MILLYARD ADVANCED MEDICAL PRODUCTS, LLC | DKPI-21073-007 | 00850017421400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |