IMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
Received Nov 18, 2011 · Event occurred Sep 25, 2011
Report 2050012-2011-07625 · MDR key 2342629
Device
Generic name
Immunochemical, Ceruloplasmin
Manufacturer
Beckman Coulter, Inc.Model number
IMMAGE AAT REAGENTCatalog number
447740
Lot number
M105003
Product problems
- Incorrect Or Inadequate Test Results
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER CALLED TO REPORT THAT THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM GENERATED ERRONEOUS ALPHA-ANTITRYPSIN (AAT) RESULTS. CUSTOMER ALSO REPORTED LOW QUALITY CONTROL RECOVERY. THE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT APPEARS AS THOUGH THIS WAS A REAGENT-SPECIFIC ISSUE, AND NOT AN INSTRUMENT ISSUE, AS THE PROBLEMS OCCURRED ONCE THIS REAGENT LOT WAS USED. A SERVICE REQUEST WAS NOT GENERATED. CUSTOMER STATED THAT ALTHOUGH ERRONEOUS RESULTS WERE GENERATED, PATIENT TREATMENT WAS NOT AFFECTED.
Additional Manufacturer Narrative
THE ROOT CAUSE OF THE ISSUE WAS NOT DETERMINED, BUT IT APPEARS AS THOUGH THE ISSUE WAS REAGENT-SPECIFIC. (NOTE: THE BECKMAN COULTER, INC. IDENTIFIER FOR THIS REPORT IS (B)(4)). REAGENT-SPECIFIC ISSUE.