CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. A SPECIFIC ANALYZER ISSUE WAS NOT SUSPECTED AS THE ISSUE OCCURRED ON MULTIPLE ANALYZERS. THE PROVIDED REACTION MONITORS DID NOT INDICATE ANY ISSUES. ANY INTERFERENCE FROM THE PATIENT'S MEDICATION WAS EXCLUDED. AN INTERFERENCE FROM A GAMMOPATHY WAS POSSIBLE.

Additional Manufacturer Narrative

(B)(4). THIS EVENT OCCURRED IN (B)(6). EXPIRATION DATE WAS PROVIDED AS "02/2018."

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE RESULTS FOR ONE PATIENT WHEN DILUTIONS WERE PERFORMED. THE CUSTOMER USED A COBAS 6000 C (501) MODULE. THE SERIAL NUMBER OF THE ANALYZER WAS REQUESTED, BUT IT WAS NOT PROVIDED. THE UNDILUTED RESULT WAS 149.32 MG/L WITH A DATA FLAG. WITH A 1:3 DILUTION, THE RESULT WAS 51.86 MG/L WITH A DATA FLAG. WITH A 1:5 DILUTION, THE RESULT WAS 14.66 MG/L WITH A DATA FLAG. WITH A 1:10 DILUTION, THE RESULT WAS 0.00 MG/L. WITH A 1:20 DILUTION, THE RESULT WAS 0.00 MG/L. WITH A 1:50 DILUTION, THE RESULT WAS 0.00 MG/L. THE SAMPLE WAS REPEATED ON COBAS 8000 C 702 MODULE. THE SERIAL NUMBER OF THE ANALYZER WAS REQUESTED, BUT IT WAS NOT PROVIDED. THE UNDILUTED RESULT WAS 203.41 MG/L WITH A DATA FLAG. WITH A 1:3 DILUTION, THE RESULT WAS 71.51 MG/L WITH A DATA FLAG. WITH A 1:5 DILUTION, THE RESULT WAS 19.07 MG/L. WITH A 1:10 DILUTION, THE RESULT WAS 0.00 MG/L. WITH A 1:20 DILUTION, THE RESULT WAS 0.00 MG/L. THE RESULT OF 51.68 MG/L WAS REPORTED TO THE PHYSICIAN. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CUSTOMER HAD NO PROBLEMS WITH OTHERS ASSAYS OR PATIENT RESULTS.