HBA1C III TINA-QUANT HEMOGLOBIN A1C III

Additional Manufacturer Narrative

NA.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH A1C-3 TINA-QUANT HEMOGLOBIN A1C GEN.3 ON A COBAS 6000 C (501) MODULE. THE HBA1C RESULT FROM THE SAMPLE DID NOT AGREE WITH THE PATIENT'S CLINICAL STATUS. THE SAMPLE RESULTED IN AN HBA1C VALUE OF 9.7 % AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS SCHEDULED TO HAVE SURGERY AND IT WAS CANCELED UNTIL A NEW SAMPLE COULD BE COLLECTED FROM THE PATIENT. THE PATIENT'S SURGERY WAS RESCHEDULED. THE DOCTOR QUESTIONED THE 9.7 % VALUE AS IT DID NOT MATCH THE PATIENT'S CLINICAL CONDITION AND PATIENT HISTORY. ON (B)(6) 2022, A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT, RESULTING IN AN HBA1C VALUE OF 5.9 %. THIS VALUE WAS DEEMED CORRECT. THE SERIAL NUMBER OF THE C501 ANALYZER IS (B)(4).

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER PERFORMED INSTRUMENT CHECKS AND RAN PRECISION STUDIES. THE SAMPLE PROBE WAS REPLACED DUE TO A SLIGHT BEND. CUVETTE STATIONS AND PROBE STATIONS WERE ADJUSTED. THE GEAR PUMP PRESSURE WAS ADJUSTED. CUVETTE AND PROBE RINSE LEVELS WERE GOOD. THE INSTRUMENT CHECK PASSED. THE ENGINEER ALSO DETERMINED THERE WAS SALT CRYSTAL BUILDUP ON THE TOP OF THE CUVETTES, WHICH INDICATES SPLASHING. AS A LEAK WAS SUSPECTED, THE VACUUM BOTTLES, A VALVE, CUVETTES, AND ALL RINSE MECHANISM TUBING WERE REPLACED. AFTER THESE ACTIONS, THE ISSUE WAS RESOLVED. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.