FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM
MDR report key: 2024460
·
Received March 19, 2011
Report
- Report Number
- 2122870-2011-00686
- Event Type
- Malfunction
- Date Received
- March 19, 2011
- Date of Event
- February 16, 2011
- Report Date
- February 18, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K023764
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
QC SHIFTED LOW AFTER SWITCHING TO A DIFFERENT REAGENT LOT. THE CUSTOMER IS WORKING WITH BCI ASSAY APPLICATIONS SUPPORT FOR TROUBLESHOOTING.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING LOWER THAN EXPECTED FREE T3 (FT3) RESULTS GENERATED BY THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM THAT DID NOT CORRELATE WITH THE PATIENT'S OTHER THYROID TEST RESULTS. THE ACTUAL PATIENT RESULTS WERE NOT PROVIDED BY THE CUSTOMER. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXL 800 ACCESS® IMMUNOASSAY SYSTEM | DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXI 800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |