FDA Adverse Event
Malfunction
Summary report: N
UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM
MDR report key: 3974312
·
Received August 1, 2014
Report
- Report Number
- 2122870-2014-00555
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Date of Event
- July 9, 2014
- Report Date
- July 9, 2014
- Manufacturer
- BECKMAN COULTER
- Product Code
- JJE
- PMA / PMN Number
- K023764
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE SAMPLE PROBE. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED SAMPLE PNP SYSTEM ERRORS INVOLVING THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED ASSOCIATED WITH THIS EVENT. PATIENT CARE WAS NOT IMPACTED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSESSED THE INSTRUMENT AT THE FACILITY AND NOTED CARRYOVER ON THE SAMPLE PROBE. THE FSE REPLACED THE SAMPLE PROBE AND RESOLVED THE REPORTED ISSUE. NO FURTHER ISSUES WERE NOTED. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 450102 | UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | JJE | BECKMAN COULTER | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |