FDA Adverse Event
Malfunction
Summary report: N
ABL90 FLEX PLUS ANALYZER
MDR report key: 24494700
·
Received March 3, 2026
Report
- Report Number
- 3002807968-2026-00018
- Event Type
- Malfunction
- Date Received
- March 3, 2026
- Date of Event
- February 12, 2026
- Report Date
- March 9, 2026
- Manufacturer
- RADIOMETER MEDICAL APS
- Product Code
- CHL
- UDI-DI
- 05700693930923
- PMA / PMN Number
- K160153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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 EXPERIENCED A SOFTWARE REBOOT AFTER TAKING A MEASUREMENT ON A ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6)). THE CUSTOMER HAS NOT EXPRESSED COMPLAINTS AT THIS SITE. ISSUE IS IDN (INTEGRATED DELIVERY NETWORK IN HEALTHCARE) WIDE AND ISSUES WERE FOUND AFTER LOOKING INTO IT MORE. THE PROVIDED SERVICE DUMP LOGS FIVE CRASHES FROM 12FEB2026 TO 16FEB2026, IN TWO OF THE CRASHES THE SAMPLE WAS LOST. THE FIRST SAMPLE LOST WAS ON 12FEB2026.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52538 | ABL90 FLEX PLUS ANALYZER | ABL90 FLEX PLUS ANALYZER | CHL | RADIOMETER MEDICAL APS | 393-092 | 05700693930923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |