COBAS INTEGRA URIC ACID 2

Additional Manufacturer Narrative

D4 UNIQUE IDENTIFIER (UDI) # (B)(4). THE LAST CALIBRATION WAS DONE ON 21-SEP-2020 AND WAS ACCEPTABLE. THE QC RECOVERY WAS ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE CHECKED THE INSTRUMENT BUT WAS UNABLE TO DETERMINE ROOT CAUSE OF THE ISSUE. THERE IS NO INDICATION FOR A PERFORMANCE ISSUE OF REAGENT OR INSTRUMENT. THE CUSTOMER SUSPECTED AN INTERFERENCE. THE PATIENTS MAY BE RECEIVING THE MEDICATION KRYSTEXXA, BUT THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION REGARDING IF THE PATIENTS WERE TAKING THE PLACEBO OR NOT. THE PATIENT SAMPLES COULD NOT BE PROVIDED FOR INVESTIGATION. BASED ON THE LACK OF DATA PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE URIC ACID RESULTS FOR 7 PATIENT SAMPLES FROM 2 PATIENTS ON A COBAS INTEGRA 400 PLUS MODULE. THE REPEATED RESULTS WERE TESTED ON A DIFFERENT ANALYZER IN A CENTRAL LAB UNLESS STATED OTHERWISE. SAMPLES FROM PATIENT 1 (ID: 204): THE INITIAL RESULT WAS 0.9 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. ON (B)(6) 2020 THE INITIAL RESULT WAS 2.4 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. ON (B)(6) 2020 THE INITIAL RESULT WAS 4.0 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. SAMPLE D: ON (B)(6) 2020 THE INITIAL RESULT WAS 5.1 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. THIS SAMPLE WAS SENT OUT TO LABCORP AND THE RESULT WAS ALSO <0.2 MG/DL. SAMPLES FROM PATIENT 2 (ID: (B)(6)): THE INITIAL RESULT WAS 1.4 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. ON (B)(6) 2020 THE INITIAL RESULT WAS 4.1 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. ON (B)(6) 2020 THE INITIAL RESULT WAS 2.7 MG/DL AND THE REPEATED RESULT WAS <0.2 MG/DL. THE REAGENT LOT NUMBER IS 46051301 WITH AN EXPIRATION DATE OF 28-FEB-2021. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. BOTH PATIENTS ARE INVOLVED IN A STUDY FOR MEDICATION WHICH LOWERS URIC ACID.