FDA Adverse Event
Malfunction
Summary report: N
DILUENT
MDR report key: 793952
·
Received December 4, 2006
Report
- Report Number
- 2919069-2006-00117
- Event Type
- Malfunction
- Date Received
- December 4, 2006
- Date of Event
- January 30, 2006
- Manufacturer
- ABBOTT DIAGNOSTICS DIVISION/CELLDYN
- Product Code
- GIF
- PMA / PMN Number
- k030513
- Removal / Correction Number
- 2919069-2/7/06-001-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION TO DETERMINE THE CAUSE OF THE STABILITY ISSUE IS ONGOING. THIS IS A FINAL REPORT.
Description of Event or Problem · 1
INSTABILITY OF DILUENT LIST #08H17-01 AND #99226-01 WAS IDENTIFIED WHEN TESTED ON THE CELL-DYN 1800 ANALYZER. IT WAS DETERMINED THAT PT RESULTS FOR HEMOGLOBIN MAY BE DECREASED UP TO 1.0 G/DL. CUSTOMERS WERE REQUIRED TO DISCONTINUE THE USE OF ALL LOTS OF DILUENT LIST #08H17-01 AND #99226-01. A RECALL WAS ISSUED 02/09/2006. ABBOTT HAS NOT RECEIVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THE AFFECTED LOTS OF DILUENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DILUENT | DILUENT | GIF | ABBOTT DIAGNOSTICS DIVISION/CELLDYN | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | CELL-DYN 1800 ANALYZER LIST 7H77-01 |