FDA Adverse Event
Malfunction
Summary report: N
IMMAGE RHEUMATOID FACTOR (RF)
MDR report key: 2438297
·
Received February 3, 2012
Report
- Report Number
- 2050012-2012-00330
- Event Type
- Malfunction
- Date Received
- February 3, 2012
- Date of Event
- December 30, 2011
- Report Date
- January 13, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- DHR
- PMA / PMN Number
- K963048
- Removal / Correction Number
- 2050012-01/26/2012-003C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS ISSUE IS CURRENTLY UNDER INVESTIGATION.
Additional Manufacturer Narrative · 1
CUSTOMER RECEIVED A NEW LOT OF RHEUMATOID FACTOR, AND BECKMAN COULTER CONSIDERS THAT NO FURTHER INVESTIGATION IS REQUIRED FOR THIS EVENT.
Description of Event or Problem · 1
CUSTOMER REPORTED ERRONEOUS HIGH TEST RESULTS WERE OBTAINED WHEN USING THE IMMAGE RHEUMATOID FACTOR (RF) ON THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. CUSTOMER REPORTED AN INCREASE IN THE NUMBER OF RF POSITIVE PATIENT RESULTS, WITH MOST OF THE RESULTS RECOVERING A VALUE SLIGHTLY ABOVE 20 IU/ML. CALIBRATION AND QUALITY CONTROL DATA WERE EVALUATED AND ARE ACCEPTABLE. THE ERRONEOUS HIGH TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR AFFECT TO PATIENT MANAGEMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMMAGE RHEUMATOID FACTOR (RF) | SYSTEM, TEST, RHEUMATOID FACTOR | DHR | BECKMAN COULTER, INC. | IMMAGE RF | M101865 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMMAGE 800 IMMUNOCHEMISTRY SYSTEM |