ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR TINA-QUANT IMMUNOGLOBULIN A GEN. 2 (IGA). THE SAMPLE INITIALLY RESULTED AS 36 MG/DL ON A C501 ANALYZER AND THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PHYSICIAN. ON (B)(6) 2015, THE CUSTOMER PERFORMED ELECTROPHORESIS ON THE SAMPLE AND FOUND A PEAK FOR IGA AT 61%. REFER TO THE ATTACHMENT FOR THE SPECIFIC ELECTROPHORESIS DATA. FOR THE ELECTROPHORESIS RESULTS, IT WAS STATED THAT THERE WAS "PRESENCE OF TWO MONOCLONAL COMPONENTS, ONE IS BETA- GLOBULIN, WHICH CORRESPONDS TO 26% (3.02 G/DL) AND ANOTHER ONE IS GAMA- GLOBULIN, WHICH CORRESPONDS TO 2% (0.23 G/DL) FROM TOTAL PROTEINS." THE RESULT FROM THE C501 ANALYZER WAS NOT CONSISTENT WITH THE ELECTROPHORESIS RESULT OR PATIENT CONDITION. THE LABORATORY CALLED THE DOCTOR AND INFORMED THE DOCTOR OF THE ELECTROPHORESIS RESULTS. IT WAS THEN DECIDED TO DILUTE THE SAMPLE IN ORDER TO CHECK FOR A RESULT THAT WAS IN ACCORDANCE WITH THE ELECTROPHORESIS RESULTS. THE SAMPLE WAS DILUTED 1:10 AND THE IGA RESULT WAS 24 MG/DL. THE SAMPLE WAS DILUTED 1:20 AND THE IGA RESULT WAS 671 MG/DL. THE SAMPLE WAS REPEATED AGAIN WITHOUT DILUTION, RESULTING AS 23 MG/DL FOR IGA. THE SAMPLE WAS ALSO REPEATED AGAIN WITH A 1:20 DILUTION, RESULTING AS 840 MG/DL FOR IGA. ACCORDING TO THE CUSTOMER, ONLY THE RESULTS OBTAINED WITH THE 1:20 DILUTION WERE IN ACCORDANCE WITH THE ELECTROPHORESIS RESULTS. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE C501 ANALYZER SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. A POSSIBLE ROOT CAUSE MAY BE RELATED THE CHARACTERISTICS OF THE PATIENT SAMPLE. THE INFORMATION PROVIDED INDICATED THE PATIENT HAS MYELOMA. GAMMOPATHY MAY BE A CONSEQUENCE OF MYELOMA. PRODUCT LABELING STATES THAT GAMMOPATHY MAY CAUSE INTERFERENCE WITH THE IGA ASSAY. IT WAS ALSO REPORTED THAT THE INSTRUMENT HAD A LOT OF ISSUES RELATED TO PREVENTIVE MAINTENANCE AND THESE HAVE SINCE BEEN CORRECTED. THE MAINTENANCE STATUS OF THE INSTRUMENT MAY ALSO BE A POSSIBLE ROOT CAUSE.