FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT)
MDR report key: 2060391
·
Received April 15, 2011
Report
- Report Number
- 2050012-2011-01158
- Event Type
- Malfunction
- Date Received
- April 15, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 16, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- DHR
- PMA / PMN Number
- K971788
- Removal / Correction Number
- Z-2887-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE INFORMATION WAS PROVIDED BY THE CUSTOMER. NO SYSTEM ISSUES WERE NOTED. THIS IS A REAGENT RELATED ISSUE. THE ISSUE WAS RESOLVED BY CHANGING REAGENTS LOTS.
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 OBTAINING FALSELY POSITIVE RHEUMATOID FACTOR (RF) RESULTS THAT WERE GENERATED BY THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE PATIENT RESULTS WERE REPEATED USING A NEW REAGENT LOT. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT) | SYSTEM, TEST, RHEUMATOID FACTOR | DHR | BECKMAN COULTER INC. | RF REAGENT | M911529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |