FDA Adverse Event
Malfunction
Summary report: N
ABL90 FLEX PLUS ANALYZER
MDR report key: 24577766
·
Received March 12, 2026
Report
- Report Number
- 3002807968-2026-00028
- Event Type
- Malfunction
- Date Received
- March 12, 2026
- Date of Event
- February 26, 2026
- Report Date
- March 12, 2026
- Manufacturer
- RADIOMETER MEDICAL APS
- Product Code
- CHL
- UDI-DI
- 05700693930923
- PMA / PMN Number
- K160153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
RADIOMETER REFERENCE NUMBER: (B)(4) ACCORDING TO THE COMPLAINT, THE CUSTOMER REPORTED THAT WHEN THE PATIENT ORDER IS SCANNED AND ASPIRATED THE SAMPLE WITH THE BLOOD GAS ANALYZER ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6), THE PROGRAM SHOWS AN UNEXPECTED ERROR WITH A BLUE SCREEN THAT CAUSES REBOOTING OF THE ANALYZER. THE SERVICE DUMP LOGS TWO CRASHES: (B)(6) 2026 23:11:58 AND (B)(6) 2026 23:48:29. THE SAMPLE WAS LOST IN BOTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 641725 | ABL90 FLEX PLUS ANALYZER | ABL90 FLEX PLUS ANALYZER | CHL | RADIOMETER MEDICAL APS | 393-092 | 05700693930923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |