FDA Adverse Event
Malfunction
Summary report: N
UNICEL DXC 800 SYNCHRON SYSTEM
MDR report key: 12316817
·
Received August 12, 2021
Report
- Report Number
- 2050012-2021-00053
- Event Type
- Malfunction
- Date Received
- August 12, 2021
- Date of Event
- July 24, 2021
- Report Date
- August 12, 2021
- Manufacturer
- BECKMAN COULTER
- Product Code
- JJE
- UDI-DI
- 15099590369507
- PMA / PMN Number
- K103842
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND EVALUATED THE DEVICE. THE FSE REPLACED A/B REAGENT VALVE (HAMILTON VALVE, PART NUMBER 970835) AND BUBBLE GENERATOR ASSEMBLY (PART NUMBER 466160) TO RESOLVE THE ISSUE. BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4). PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED. PATIENT DATA WAS NOT PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE UNICEL DXC 800 SYNCHRON SYSTEM GENERATED MULTIPLE FALSE LOW ACTM (ACETAMINOPHEN) PATIENT RESULTS. THE CUSTOMER NOTICED FLUID WAS LEAKING FROM REAGENT PROBE A. THE ERRONEOUS RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO CHANGE IN PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1213166 | UNICEL DXC 800 SYNCHRON SYSTEM | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | JJE | BECKMAN COULTER | DXC 800 AR PACKAGED SYSTEM | N/A | 15099590369507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |