FDA Adverse Event
Malfunction
Summary report: N
CLINICAL CHEMISTRY PHENOBARBITAL
MDR report key: 793876
·
Received December 4, 2006
Report
- Report Number
- 2018433-2006-00028
- Event Type
- Malfunction
- Date Received
- December 4, 2006
- Date of Event
- September 28, 2006
- Manufacturer
- ABBOTT MFG, INC
- Product Code
- LGQ
- PMA / PMN Number
- k993031
- Removal / Correction Number
- 2018433-9/28/06-002-C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS A FINAL REPORT. AN INVESTIGATION IS IN-PROCESS.
Description of Event or Problem · 1
ABBOTT HAS IDENTIFIED A PHENOBARBITAL PERFORMANCE ISSUE THAT IS DEMONSTRATED BY ERRATIC ELEVATED RESULTS AND/OR THE INABILITY TO CALIBRATE DUE TO IMPRECISION. A RECALL WAS ISSUED AND REPORTED UNDER 21 CFR 806 TO THE FDA DISTRICT OFFICE ON SEPTEMBER 28, 2006. ABBOTT HAS NOT RECEIVED ANY REPORT OF ADVERSE EVENTS ASSOCIATED WITH THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLINICAL CHEMISTRY PHENOBARBITAL | QUANTITATION OF PHENOBARBITAL IN HUMAN SERUM OR PLASMA | LGQ | ABBOTT MFG, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | ARCHITECT C8000 ANALYZER LIST#1G06-01 |