HCYS HOMOCYSTEINE ENZYMATIC ASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER'S PROVIDED CALIBRATION RESULTS WERE OK. UNIQUE DEVICE IDENTIFIER (UDI) (B)(4). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE HCYS HOMOCYSTEINE ENZYMATIC ASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 C 502 MODULE SERIAL NUMBER (B)(4). THE PATIENT'S INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S SAMPLE WAS REPEATED ON A C 502 MODULE AND SENT TO A DIFFERENT LABORATORY AND TESTED WITH NEPHELOMETRY METHODOLOGY. ALSO, THE CUSTOMER PERFORMED A 1:10 DILUTION WITH THE PATIENT'S SAMPLE ON AN UNKNOWN ANALYZER. ON 22-MAY-2021, THE PATIENT'S INITIAL AND REPEAT HOMOCYSTEINE RESULTS ON THE C 502 MODULE WERE 0.0 UMOL/L. ON 24-MAY-2021, THE PATIENT'S HOMOCYSTEINE RESULT WITH NEPHELOMETRY METHODOLOGY WAS 41.80 UMOL/L. ON 24-MAY-2021, THE PATIENT'S HOMOCYSTEINE RESULT WITH A 1:10 MANUAL DILUTION WAS 51 UMOL/L.

Additional Manufacturer Narrative

ON (B)(6) 2021, THE PATIENT'S HOMOCYSTEINE RESULT WITH A 1:10 MANUAL DILUTION WAS 51 UMOL/L ON A COBAS 8000 C 502 MODULE. THE CUSTOMER'S PROVIDED QC RESULTS FROM (B)(6) 2021 WERE OK, BUT THE QC RESULTS FROM THE DATE OF THE EVENT WERE REQUESTED BUT NOT PROVIDED. THE CUSTOMER'S SYSTEM ALARM TRACE WAS REQUESTED BUT NOT PROVIDED. THE CUSTOMER CONFIRMED THERE WERE NO CLOTS OR FIBRIN IN THE PATIENT'S SAMPLE. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.