LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATION

Additional Manufacturer Narrative

FIELDS D1-D4, G1, AND G5 WERE UPDATED. D4 UNIQUE IDENTIFIER (UDI): (B)(4) THE INTEGRA 400 PLUS SERIAL NUMBER WAS (B)(6) A FIELD SERVICE ENGINEER WAS DISPATCHED AND PERFORMED VARIOUS CHECKS ON THE INSTRUMENT. THE PROVIDED INSTRUMENT MESSAGE LOG CONTAINED MULTIPLE FILLING VOLUME / NO FLUID ALARMS. THESE ALARMS ARE INDICATORS OF OVERFILLED TUBES OR INCORRECT TUBE CONFIGURATION. THE INVESTIGATION DETERMINED THE MALFUNCTION IS CONSISTENT WITH A CONTAMINATED REAGENT CASSETTE. THE CAUSE OF THE CONTAMINATION COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

UNIQUE IDENTIFIER (UDI) # (B)(4). COUNTRY CODE IS (B)(6). THE SAMPLES ARRIVED AT THE LABORATORY ALREADY CENTRIFUGED. THE PREVIOUS CALIBRATION AND QC TESTS HAD ACCEPTABLE RESULTS. A CALIBRATION WAS RUN ON (B)(6) 2021, WITH A NEW CASSETTE, AND HAD ACCEPTABLE RESULTS. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE LDL_C LDL-CHOLESTEROL PLUS 3ND GENERATION RESULTS FOR 3 PATIENT SAMPLES ON A COBAS INTEGRA 400 PLUS ANALYZER. PATIENT 1: THE INITIAL RESULT WAS 250 MG/DL AND THE REPEAT RESULTS ON (B)(6) 2021 WERE 117 MG/DL AND 113 MG/DL. THE RESULT OF 250 MG/DL WAS REPORTED TO THE PATIENT. PATIENT 2: THE INITIAL RESULT WAS 131 MG/DL AND THE REPEAT RESULTS ON (B)(6) 2021 WERE 85.7 MG/DL AND 86.8 MG/DL. THE RESULT OF 86.8 MG/DL WAS OBTAINED AFTER A NEW CALIBRATION WAS DONE. IT WAS UNKNOWN IF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. PATIENT 3: THE INITIAL RESULT WAS 268 MG/DL AND THE REPEAT RESULTS ON (B)(6) 2021 WERE 174.8 MG/DL AND 176.3 MG/DL. THE RESULT OF 176.3 MG/DL WAS OBTAINED AFTER A NEW CALIBRATION WAS DONE. IT WAS UNKNOWN IF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REAGENT LOT NUMBER WAS 46178301 AND THE EXPIRATION DATE WAS (B)(6) 2021.