FDA Adverse Event
Malfunction
Summary report: N
CD SAPPHIRE, CD 4000 SYSTEMS DILUENT/SHEATH
MDR report key: 795516
·
Received December 8, 2006
Report
- Report Number
- 2919069-2006-00120
- Event Type
- Malfunction
- Date Received
- December 8, 2006
- Date of Event
- April 17, 2006
- Report Date
- November 29, 2006
- Manufacturer
- ABBOTT DIAGNOSTICS DIV/CELLDYN
- Product Code
- GKL
- PMA / PMN Number
- k051215
- Removal / Correction Number
- 2919069-11/30/06-009-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
510(K)#: K961439. THIS IS A FINAL REPORT. AN INVESTIGATION IS IN PROCESS.
Description of Event or Problem · 1
THIS MEDWATCH REPORT IS BEING FILED DUE TO THE FINDING OF TRACE ORGANIC CONTAMINANTS BEING INTRODUCED TO THE PRODUCT (CELL-DYN SAPPHIRE, CELL-DYN 4000 SYSTEMS DILUENT SHEATH) THROUGH THE MANUFACTURING WATER SYSTEM. THE INTERACTION OF TRACE ORGANIC COMPOUNDS WITH THE DILUENT/SHEATH FORMULATION MAY CAUSE HIGH PLATELET BACKGROUND READINGS ON THE CELL-DYN 4000 AND CELL-DYN SAPPHIRE SYSTEMS. NOT ALL CUSTOMERS ARE AFFECTED. A RECALL WAS ISSUED AND REPORTED UNDER 21CFR806 TO THE FDA DISTRICT OFFICE ON NOVEMBER 30, 2006. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CD SAPPHIRE, CD 4000 SYSTEMS DILUENT/SHEATH | DILUENT/SHEATH FOR USE ON THE CELL-DYN SAPPHIRE, CELL-DYN 40 | GKL | ABBOTT DIAGNOSTICS DIV/CELLDYN | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | 1H03-01, 1H02-01, -03| CELL-DYN 4000 ANALYZER LIST#S: 1H01-01, -03,| CELL-DYN SAPPHIRE ANALYZER LIST#: 8H00-01 |