FDA Adverse Event
Malfunction
Summary report: N
IMMAGE 800 IMMUNOCHEMISTRY SYSTEM
MDR report key: 2001944
·
Received February 27, 2011
Report
- Report Number
- 2050012-2011-00537
- Event Type
- Malfunction
- Date Received
- February 27, 2011
- Date of Event
- January 27, 2011
- Report Date
- January 27, 2011
- 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
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SAMPLE INFORMATION WAS NOT PROVIDED. HOWEVER, NO SAMPLE ISSUES WERE NOTED. QC AND CALIBRATION INFORMATION WAS NOT PROVIDED. SERVICE WAS NOT DISPATCHED SINCE THIS IS A REAGENT ISSUE. CHANGING REAGENT LOTS HAS RESOLVED THE ISSUE. THIS IS A REAGENT ISSUE.
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 AN ERRONEOUS HIGH RHEUMATOID FACTOR RESULTS ON UNKNOWN NUMBER OF PATIENTS GENERATED BY THE IMMAGE 800 IMMUNOCHEMISTRY. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. INITIAL PATIENT SAMPLES READINGS WERE BETWEEN 22 AND 26 IU/ML UPON REPEAT USING AN OLDER REAGENT LOWER RESULTS (<20 IU/ML ) WERE OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED SINCE THE CUSTOMER RERAN THESE SAMPLES WITH OLDER REAGENT.
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 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |