LACTATE DEHYDROGENASE ACC. IFCC VER.2

Additional Manufacturer Narrative

QC AND CALIBRATIONS WERE ACCEPTABLE. THEREFORE, A GENERAL REAGENT ISSUE WAS EXCLUDED. THE ANALYZER ALARM TRACES CONTAINED FREQUENT ALARMS FOR "ABNORMAL ASPIRATION" AND "SAMPLE SHORTAGE", INDICATING A POOR PRE-ANALYTICAL PROCESS. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE WAS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. EXAMPLE 1 HAD AN INITIAL RESULT OF 241 U/L AND A REPEAT RESULT OF 179 U/L. ON (B)(6) 2026, EXAMPLE 2 HAD AN INITIAL RESULT OF 230 U/L AND REPEAT RESULTS OF 161 U/L AND 182 U/L. EXAMPLE 3 HAD AN INITIAL RESULT OF 216 U/L AND A REPEAT RESULT OF 164 U/L.

Additional Manufacturer Narrative

THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.