CRP LATEX REAGENT

Additional Manufacturer Narrative

A BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE CUSTOMER'S PROVIDED DATA AND SUSPECTED POSSIBLE SAMPLE INTERFERENCE DUE TO THE PATIENT HAS MONOCLONAL IGM GAMMOPATHY. THE CUSTOMER WAS ADVISED TO SEND THE PATIENT¿S FUTURE SAMPLES TO ANOTHER LABORATORY TO BE TESTED ON A DIFFERENT METHODOLOGY FOR CONFIRMATION. NO SPECIFIC FAILURE MODE HAS BEEN IDENTIFIED. NO HARDWARE, EQUIPMENT, REAGENT OR CONSUMABLE MALFUNCTION WAS IDENTIFIED. THE CUSTOMER DID NOT REQUEST FOR SERVICE. BECKMAN COULTER INTERNAL IDENTIFIER IS (B)(4). SAMPLE WAS FROM AN (B)(6) YEARS OLD MALE PATIENT. OTHER PATIENT DEMOGRAPHIC INFORMATION WAS NOT PROVIDED. CUSTOMER PHONE NUMBER (B)(6). THIS IS A CORRECTED REPORT FOR MDR REPORT NUMBER: 9612296-2021-00046. UPDATE INFORMATION WITH THE CHANGE IN DEVICE, AND DEVICE MANUFACTURING SITE: PRODUCT BRAND NAME, PRODUCT CODE AND MODEL NUMBER. MANUFACTURING SITE, NAME AND ADDRESS. 510K NUMBER FOR CRP REAGENT PN OSR6299.

Description of Event or Problem

THE CUSTOMER IN (B)(6) REPORTED THE AU5800 CLINICAL CHEMISTRY ANALYZER GENERATED HIGH C-REACTIVE PROTEIN (CRP) RESULT DRAWN FROM ONE PATIENT. THE REPORTED CRP RESULT WAS AROUND 470 MG/L. ON 21JANUARY 2021, THE CUSTOMER INFORMED BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. THE PATIENT¿S PLASMA SAMPLE WAS TESTED FOR CRP ON AN UNKNOWN ANALYZER (UNKNOWN METHODOLOGY) THAT YIELDED A LOWER RESULT OF 15 MG/L. BECKMAN COULTER CTS CONFIRMED THAT THE SAMPLE WAS FROM A PATIENT WHO FOLLOWED IN THE ONCOLOGY SERVICE AT THE HOSPITAL.