FDA Adverse Event
Malfunction
Summary report: N
IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM
MDR report key: 1913229
·
Received December 2, 2010
Report
- Report Number
- 2050012-2010-01478
- Event Type
- Malfunction
- Date Received
- December 2, 2010
- Date of Event
- November 3, 2010
- Report Date
- November 3, 2010
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JQX
- PMA / PMN Number
- K962294
- Removal / Correction Number
- Z-2887-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CALIBRATION AND QC ARE ACCEPTABLE. NO SYSTEM ERROR WAS NOTED. SERVICE WAS NOT NEEDED FOR THIS EVENT AS THIS ISSUE IS REAGENT RELATED. INVESTIGATION INTO THE ROOT CAUSE OF THIS ISSUE IS ONGOING.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
...
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO FALSE POSITIVE RHEUMATOID FACTOR (RF) RESULTS GENERATED BY IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY PHYSICIANS. THERE WAS NO EFFECT TO THE PATIENT TREATMENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM | NEPHELOMETER, FOR CLINICAL USE | JQX | BECKMAN COULTER, INC. | IMMAGE 800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |