TINA-QUANT HBALC GEN. 3

Additional Manufacturer Narrative

THE ROOT CAUSE WAS CONSISTENT WITH A MAINTENANCE ISSUE. THE SERVICE ACTIONS (REPLACING THE LAMP, THE REACTION CELLS, AND THE SAMPLE PROBE) RESOLVED THE ISSUE. THERE WAS NO INDICATION OF A GENERAL PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE COBAS 6000 C501 ANALYZER SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND NOTED THE FOLLOWING: THE CUSTOMER REPLACED THE LAMP, THE REACTION CELLS AND THE SAMPLE PROBE. THE GEAR PUMP PRESSURE WAS CHECKED. BOTH LEVEL QCS ON THE DAY OF EVENT WERE SHIFTED POSITIVELY. THE CALIBRATION TRACE SHOWED MULTIPLE CALIBRATION FAILURES ON 31-AUG-2023 AND THEN PASSED AFTER MULTIPLE AIR PURGES. THE HARDWARE CHECK WAS PERFORMED AND WAS SUCCESSFUL. THE FSE TESTED THE SAMPLE 5 TIMES AS A PRECISION AND THEY WERE SUCCESSFUL. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 5 PATIENTS' SAMPLES TESTED WITH THE HBA1C ON A COBAS 6000 C501 ANALYZER. DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES WERE PROVIDED. SAMPLE 1: INITIAL RESULT: 6.5% WITH A DATA FLAG. REPEAT RESULT: 5.2%. SAMPLE 2: INITIAL RESULT: 7.1% WITH A DATA FLAG. REPEAT RESULT: 5.3%. SAMPLE 3: INITIAL RESULT: 5.7% WITH A DATA FLAG. REPEAT RESULT: 4.8% WITH A DATA FLAG. THE PHYSICIAN QUESTIONED THE REPEAT RESULTS.