FDA Adverse Event
Malfunction
Summary report: N
IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM
MDR report key: 1934086
·
Received December 21, 2010
Report
- Report Number
- 2050012-2010-01709
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- November 22, 2010
- Report Date
- November 22, 2010
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JQX
- PMA / PMN Number
- K962294
- Removal / Correction Number
- Z-2887-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
THIS FOLLOW UP IS SUBMITTED TO CORRECT TYPO'S OBSERVED IN THE ORIGINAL REPORT. THIS EVENT SHOULD HAVE BEEN FILED AS A PRODUCT PROBLEM AND A MALFUNCTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
THE CUSTOMER IS USING REAGENT LOT M908398. SERVICE WAS NOT NEEDED FOR THIS EVENT AS THIS ISSUE IS REAGENT RELATED. INVESTIGATION INTO THE ROOT CAUSE OF THIS ISSUE IS ONGOING.
Description of Event or Problem · 1
...
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED RHEUMATOID FACTOR (RF) RESULTS GENERATED BY IMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. IT IS UNKNOWN IF THE PATIENT TREATMENT WAS AFFECTED IN THIS EVENT. THE RISK OF SERIOUS INJURY WILL BE ASSUMED UPON RECUR.
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 | Other |