ARCHITECT CEA
Received Jul 9, 2015 · Event occurred Jun 27, 2015
Report 3008344661-2015-00016 · MDR key 4902890
Device
Generic name
Carcinoembryonic Antigen
Manufacturer
Abbott IrelandCatalog number
07K68-32
Lot number
50181LF00
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).
Additional Manufacturer Narrative
HISTORICAL COMPLAINT SEARCHES DETERMINED THAT THERE IS NO UNUSUAL ACTIVITY FOR THE LIKELY CAUSE LOT. COMPLAINT TRENDING REPORT REVIEW DETERMINED THAT THERE IS NO NON STATISTICAL OR ADVERSE TREND FOR THE ISSUE FOR THE PRODUCT. TESTING WAS PERFORMED WITH SERUM BASED PANEL SAMPLES WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED CEA REAGENT KIT. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION, THE ASSAY PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER STATED THAT A FALSELY DECREASED ARCHITECT CEA RESULT OF 2.38 NG/ML WAS GENERATED FOR A PATIENT SAMPLE (B)(6) THAT RETESTED AT VALUES BETWEEN 830 AND 850 NG/ML. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.