IMMUNOGLOBULIN M

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

THE CUSTOMER WAS COMPARING RESULTS FROM A COBAS INTEGRA 800 TO RESULTS FROM AN ABBOTT C4000 FOR IGM IMMUNOGLOBULIN M AND IGG IMMUNOGLOBULIN IGG. THE PATIENT SAMPLES WERE ORIGINALLY RUN ON A COBAS INTEGRA 800 BETWEEN THE DATES OF (B)(6) 2017-(B)(6) 2017. THE SAME PATIENT SAMPLES WERE THEN RUN ON A RECENTLY INSTALLED ABBOTT 4000 AS PART OF A CORRELATION STUDY. OF THE DATA PROVIDED FOR ONE THE ONE PATIENT SAMPLE, ONLY THE RESULTS FOR IGM WERE DISCREPANT. THE SPECIFIC DATE OF TESTING WAS NOT PROVIDED. THE IGM RESULT FROM THE COBAS INTEGRA 800 WAS 1841 MG/DL. THE IGM RESULT FROM THE ABBOTT C4000 WAS 1384 MG/DL. THE CUSTOMER DOES NOT KNOW WHICH RESULT IS ACCURATE. THE COBAS INTEGRA 800 RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE SERIAL NUMBER FOR THE COBAS INTEGRA 800 IS (B)(4). A FIELD ENGINEERING SPECIALIST WAS DISPATCHED TO INVESTIGATE THE COBAS INTEGRA 800. HE DID NOT FIND ANY PROBLEMS WITH THE ANALYZER. HE PERFORMED PRECISION TESTING WHICH PASSED. THE CUSTOMER RAN QC WHICH PASSED. REVIEW OF THE PROVIDED CALIBRATION AND QC DATA FOUND BOTH WERE ACCEPTABLE. AS THE RESULT WAS ABOVE THE MEASURING RANGE FOR THE ASSAY, A GAMMOPATHY CANNOT BE EXCLUDED FOR THIS PATIENT. PRODUCT LABELING FOR THE ASSAY DOCUMENTS THIS INTERFERENCE.

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.