PREA PREALBUMIN

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

Description of Event or Problem

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR PREA PREALBUMIN (PREA) ON A COBAS 8000 C 502 MODULE (C502). IT WAS ASKED, BUT IT IS NOT KNOWN IF AN ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE RESULTED AS 32 MG/DL WHEN TESTED ON THE C502 ANALYZER. WHEN THE SAMPLE WAS TESTED ON AN OLYMPUS AU480 ANALYZER USING THE N-ASSAY TIA PREALBUMIN NITTOBO (MADE IN (B)(6)), IT RESULTED AS 3.5 MG/DL. IT IS UNKNOWN WHICH VALUE IS CORRECT. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE C502 ANALYZER SERIAL NUMBER WAS ASKED FOR, BUT NOT PROVIDED.

Additional Manufacturer Narrative

THE COMPLAINED SAMPLE WAS FOUND TO BE TURBID. THE SAMPLE WAS EVALUATED USING IMMUNOELECTROPHORESIS AND WAS FOUND TO CONTAIN POLYCLONAL IGG AND IGM-KAPPA. THE SAMPLE WAS ASSUMED TO BE TURBID DUE TO THE PRESENCE OF THESE ABNORMAL IMMUNOGLOBULINS. AFTER IMMUNOABSORPTION OF THE IGG WITH PROTEIN G, THE PREA MEASURING RESULTS ON C502 WENT DOWN. IT IS ASSUMED THAT THE ROOT CAUSE FOR THE FALSELY ELEVATED RESULTS IS CAUSED BY IGM-KAPPA AND/OR BY TURBIDITY DUE TO HIGH IGG CONCENTRATION. GAMMOPATHY, IN PARTICULAR TYPE IGM (B)(4), MAY CAUSE UNRELIABLE RESULTS AS STATED IN PRODUCT LABELING.