FDA Adverse Event
Malfunction
Summary report: N
ABL90 FLEX PLUS ANALYZER
MDR report key: 18675173
·
Received February 9, 2024
Report
- Report Number
- 3002807968-2024-00010
- Event Type
- Malfunction
- Date Received
- February 9, 2024
- Date of Event
- February 3, 2024
- Report Date
- February 9, 2024
- Manufacturer
- RADIOMETER MEDICAL APS
- Product Code
- CHL
- PMA / PMN Number
- K160153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT IN B3 IS ESTIMATED.
Description of Event or Problem · 0
ACCORDING TO THE COMPLAINT, WHEN ANALYZING A SAMPLE, THE PATIENT ID LAYOUT ON THE ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER: (B)(6) IS NOT LOOKING CORRECT. THE SAME PATIENT ID IS USED ON ALL SAMPLES, EVEN THOUGH NOTHING HAS BEEN ENTERED BY THE USER. WHEN THE USER WAS CHECKING AN EARLIER SAMPLE RESULT, THIS SAME PATIENT ID IS SHOWN ON THE PATIENT ID SCREEN. HOWEVER, CORRECT RESULTS WERE TRANSMITTED VIA LIS. NO REPORTS OF DEATH OR SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1338658 | ABL90 FLEX PLUS ANALYZER | ABL90 FLEX PLUS ANALYZER | CHL | RADIOMETER MEDICAL APS | 393-092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |