TINA-QUANT HEMOGLOBIN A1CDX GEN. 3

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS C513 ANALYZER COMMERCIAL SYSTEM. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 9.3 %. THE PHYSICIAN QUESTIONED THE RESULT AS IT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 6.2 %. THE REPEAT VALUE WAS DEEMED CORRECT AND MATCHED THE PATIENT'S HISTORY.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C513 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE LAST CALIBRATION PERFORMED ON 18-FEB-2024 WAS ACCEPTABLE. THE CUSTOMER STATED THAT CONTROLS WERE ACCEPTABLE PRIOR TO THE EVENT. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARMS WERE OBSERVED ON THE DAY OF THE EVENT. THE FIELD SERVICE ENGINEER COULD NOT DETERMINE A CAUSE. THE CUSTOMER STATED THE ISSUE WAS RELATED TO THE PATIENT SAMPLE. SAMPLES RUN BEFORE AND AFTER THE QUESTIONABLE SAMPLE SHOWED RESULTS THAT COULD BE DUPLICATED. THE SYSTEM FLUIDICS, MECHANICAL ADJUSTMENTS, AND WASHES WERE CHECKED. ALL CALIBRATION AND CONTROLS WERE ACCEPTABLE. THE CUSTOMER INDICATED THAT THE QUESTIONABLE SAMPLE MAY NOT HAVE BEEN MIXED PRIOR TO BEING RUN. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING.