ACCESS CEA

Additional Manufacturer Narrative

THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, AND WEIGHT. (B)(6). A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO ASSESS THE INSTRUMENT'S PERFORMANCE. THE FSE PERFORMED PRESSURE SENSOR CALIBRATION; NO HARDWARE MALFUNCTIONS WERE IDENTIFIED THAT MAY HAVE CAUSED, OR CONTRIBUTED, TO THIS EVENT. THE IMPLICATED REAGENT PACK WAS DISCARDED BY THE CUSTOMER AND IS NOT AVAILABLE FOR INVESTIGATION. INVESTIGATION OF THE EVENT DETERMINED THAT AN ERROR OCCURRED ON THE MANUFACTURER'S REAGENT PACK FILL LINE. DUE TO THE ERROR, PARTIALLY FILLED REAGENT PACKS WERE RELEASED FOR USE. WHEN USED TO ANALYZE PATIENT SAMPLES, PARTIALLY FILLED REAGENT PACKS COULD CAUSE NO VALUE/QSD-FLAGGED RESULTS. (B)(4).

Description of Event or Problem

THE CUSTOMER REPORTED OBTAINING TWO (2) NO VALUE/QSD-FLAGGED (INSUFFICIENT SAMPLE OR REAGENT VOLUME DISPENSED) CARCINOEMBRYONIC ANTIGEN (ACCESS CEA) PATIENT RESULTS ON THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, SERIAL NUMBER (B)(4). THE CUSTOMER DID NOT INDICATE IF THESE SAMPLES WERE REANALYZED AND WHAT RESULTS THEY OBTAINED IF REANALYSIS DID OCCUR. UPON VISUAL INSPECTION, THERE WERE NO SIGNS OF REAGENT PACK LEAKAGE. NONE OF THE QSD-FLAGGED ACCESS CEA RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. CALIBRATION AND QUALITY CONTROL (QC) DATA WERE NOT PROVIDED FOR THIS EVENT. THE CUSTOMER DID NOT PROVIDE SPECIFIC DETAILS REGARDING THE PATIENT SAMPLES OR SAMPLE PROCESSING. THERE WAS NO INDICATION OF SAMPLE INTEGRITY ISSUES RELATED TO THIS EVENT. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE.