TINA-QUANT HEMOGLOBIN A1CDX GEN. 3

Additional Manufacturer Narrative

THE C503 ANALYZER SERIAL NUMBER WAS (B)(6). THE COBAS PURE ANALYZER SERIAL NUMBER WAS NOT PROVIDED.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 2 PEDIATRIC PATIENT SAMPLES TESTED FOR TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS C 503 ANALYTICAL UNIT AND A COBAS PURE INSTRUMENT COMPARED TO AN UNSPECIFIED ELECTROPHORESIS METHOD. ON (B)(6) 2024 "PATIENT 2" RESULT FROM THE COBAS PURE INSTRUMENT WAS 6.2% (44.2 MMOL/MOL). ON (B)(6) 2024 THE REPEAT FROM THE C503 ANALYZER WAS 5.97% (41.7 MMOL/MOL). THE REPEAT RESULT FROM THE ELECTROPHORESIS METHOD WAS 5.6% (37 MMOL/MOL). ON (B)(6) 2024 "PATIENT 1" RESULT FROM THE C503 ANALYZER WAS 5.86% (40.5 MMOL/MOL). THE REPEAT RESULT WAS 5.72% (39 MMOL/MOL). THE REPEAT RESULT FROM THE ELECTROPHORESIS METHOD WAS 5.4% (35 MMOL/MOL). BASED ON THE REFERENCE RANGES USED BY THE CUSTOMER, THE RESULTS FROM THE COBAS C503 ANALYZER AND COBAS PURE INSTRUMENT ARE CONSIDERED HIGH RISK FOR DIABETES AND THE RESULTS FROM THE ELECTROPHORESIS METHOD ARE DEEMED NORMAL.

Additional Manufacturer Narrative

THE PROBES AND RINSE LEVELS FOR CELLS AND PROBES WERE REPORTEDLY CORRECTLY ADJUSTED. THE CELLS HAVE NOT BEEN REPLACED SINCE THE INSTRUMENT WAS INSTALLED; THE CELLS SHOULD BE REPLACED MONTHLY AS PART OF ROUTINE MAINTENANCE. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.