UA2

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR NINE PATIENT SAMPLES TESTED WITH UA2 URIC ACID VER.2 ON COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE INITIAL VALUES WERE REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. THE FIRST SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.5 MG/DL AND IT REPEATED AS 3.12 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.7 MG/DL AND IT REPEATED AS 5.89 MG/DL. THE THIRD SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 1.6 MG/DL AND IT REPEATED AS 5.06 MG/DL. THE FOURTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.4 MG/DL AND IT REPEATED AS 4.13 MG/DL. THE FIFTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.4 MG/DL AND IT REPEATED AS 3.63 MG/DL. THE SIXTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.7 MG/DL AND IT REPEATED AS 4.81 MG/DL. THE SEVENTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 1.1 MG/DL AND IT REPEATED AS 5.48 MG/DL. THE EIGHTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 2.4 MG/DL AND IT REPEATED AS 4.2 MG/DL. THE NINTH SAMPLE INITIALLY RESULTED IN A URIC ACID VALUE OF 0.8 MG/DL AND IT REPEATED AS 4.2 MG/DL.

Additional Manufacturer Narrative

THE CUSTOMER PROVIDED ADDITIONAL INFORMATION IN RELATION TO THE 9 COMPLAINED PATIENT SAMPLES. REFER TO THE ATTACHMENT FOR THE PATIENT DATA, INCLUDING RELEVANT TEST DATA FOR SOME OF THE SAMPLES.

Additional Manufacturer Narrative

CALIBRATION AND CONTROLS RECOVERED WITHIN SPECIFICATIONS. A GENERAL PRODUCT ISSUE CAN BE EXCLUDED. UPON REVIEW OF THE ALARM TRACE, ABNORMAL ASPIRATION ALARMS TOOK PLACE ON (B)(6)2023 AND (B)(6)2023. A HARDWARE CHECK WAS PERFORMED AND WAS WITHIN SPECIFICATIONS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE. THE ISSUE IS CONSISTENT WITH INCORRECT PRE-ANALYTIC SAMPLE HANDLING.