ALBT2 TINA-QUANT ALBUMIN GEN.2

Additional Manufacturer Narrative

THE INITIAL MICROALBUMIN VALUE OF 3720 MG/L WAS MEASURED USING DECREASED SAMPLE VOLUME. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. ACCORDING TO THE PROVIDED PATIENT MEDICATIONS, AN INTERFERENCE IS NOT EXPECTED. THE ISSUE IS RELATED TO THE PATIENT SAMPLE. THE SAMPLE WAS VERY TURBID, EVEN AFTER CENTRIFUGATION. RE-MEASUREMENT OF THE SAMPLE WAS NOT POSSIBLE AS THE CUSTOMER DID NOT STORE IT AT THE REQUIRED TEMPERATURE. MEDWATCH FIELD D10 HAS BEEN UPDATED.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C 701 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT'S URINE SAMPLE TESTED WITH TPUC3 (TOTAL PROTEIN) ON A COBAS 8000 COBAS C 701 MODULE. THE TOTAL PROTEIN RESULT WAS DEEMED IMPLAUSIBLE BASED ON THE PATIENT'S HISTORY, CONDITION, AND MEASURED MICROALBUMIN VALUE. AFTER FURTHER MEASUREMENTS, DISCREPANCIES IN RESULTS ALSO OCCURRED FOR THE ALBT2 TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN) ASSAY. THE CUSTOMER NOTED THAT THE SAMPLE APPEARED CLOUDY EVEN AFTER CENTRIFUGATION. THIS MEDWATCH WILL APPLY TO THE MICROALBUMIN ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TOTAL PROTEIN ASSAY. THE URINE SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES: TOTAL PROTEIN= 1620 MG/L. MICROALBUMIN = 3720 MG/L. THE SYSTEM PHOTOMETER CHECKS SHOWED A HIGH ABSORBANCE SINCE 23-MAY-2023. AN IN-HOUSE TECHNICIAN AT THE CUSTOMER SITE CHANGED THE HEAT CUT FILTER ON THE ANALYZER. THE PHOTOMETER CHECK WAS OK AFTER CHANGING THE HEAT CUT FILTER. FURTHER REPEATS OF THE SAMPLE OCCURRED ON 29-SEP-2023 AFTER THE HEAT CUT FILTER WAS CHANGED. THE CUSTOMER NOTED THE SAMPLE HAD BEEN STORED AT 4 DEGREES CELCIUS AFTER INITIAL TESTING. THE SAMPLE WAS MANUALLY DILUTED 1:2 AND REPEATED ON 29-SEP-2023, RESULTING IN THE FOLLOWING VALUES: TOTAL PROTEIN= 88.5 MG/L RAW VALUE AND 177 MG/L WHEN ACCOUNTING FOR THE DILUTION FACTOR. MICROALBUMIN = 651.8 MG/L RAW VALUE AND 1303.6 MG/L WHEN ACCOUNTING FOR THE DILUTION FACTOR. THE SAMPLE WAS REPEATED USING A 1:50 AUTOMATIC DILUTION ON 29-SEP-2023, RESULTING IN THE FOLLOWING VALUES: TOTAL PROTEIN= 159.0 MG/L. MICROALBUMIN = 1354.1 MG/L.

Additional Manufacturer Narrative

ON (B)(6) 2023, THE PATIENT HAD A URINE TOTAL PROTEIN RESULT OF 976 MG/L AND A URINE ALBUMIN RESULT OF 821 MG/L.