TINA-QUANT IGM GEN.2

Additional Manufacturer Narrative

THE CUSTOMER STATED THAT THE PATIENT HAS GAMMOPATHY. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH THE GAMMOPATHY OF THE PATIENT. ADDITIONALLY, THE CUSTOMER USED A 1:10 INSTRUMENT DILUTION. THE TINA-QUANT IGM GEN.2 ASSAY IS AUTOMATICALLY PRE-DILUTED BY THE ANALYZER AT A 1:21 STANDARD PRE-DILUTION. BY ORDERING THE 1:10 INSTRUMENT DILUTION, THE ANALYZER WILL CANCEL THE AUTOMATIC PRE-DILUTION OF THE TEST. QC DATA FROM JUNE 2024 SHOWED IMPRECISION, WITH HIGH AND LOW RESULTS THAT WERE WITHIN 3 STANDARD DEVIATIONS OF THE MEAN. THE CALIBRATION DATA SHOWED SOME DEGREE OF CALIBRATION FAILURE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C702 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT IGM GEN.2 ON A COBAS 8000 C702 MODULE. THE PATIENT SAMPLE WAS ANALYZED VIA ELECTROPHORESIS, RESULTING IN AN IGM VALUE OF 50 G/L ON (B)(6) 2024. WHEN THE PATIENT SAMPLE WAS TESTED ON THE C 702 ANALYZER, IT RESULTED IN VALUES OF 4.249 G/L ON (B)(6) 2024, 4.787 G/L ON (B)(6) 2024, AND 5.152 G/L ON (B)(6) 2024. THE PATIENT SAMPLE RESULTED IN AN ADDITIONAL VALUE OF 4.23 G/L WHEN TESTED ON THE C702 ANALYZER. THE SAMPLE WAS AUTOMATICALLY DILUTED ON THE ANALYZER 1:10 AND REPEATED, RESULTING IN A RAW VALUE OF 0.529 G/L ON (B)(6) 2024. THIS CALCULATES TO A FINAL VALUE OF 5.29 G/L.