Description of Event or Problem · 0
RADIOMETER COMPLAINT REFERENCE: (B)(4). ACCORDING TO COMPLAINT, CUSTOMER REPORTED THAT THERE HAVE BEEN 5 DIFFERENT PATIENT SAMPLES THAT HAVE HAD VERY LOW TOTAL HEMOGLOBIN (THB) RESULTS RANGING FROM 0.1 TO 12 G/L BETWEEN (B)(6) 2026 FROM BLOOD GAS ANALYZER ABL90 FLEX PLUS ANALYZER (SERIAL NUMBER (B)(6)). THERE WERE NO ERROR MESSAGES ON THE SAMPLES AND SAMPLES FROM THESE PATIENTS PERFORMED IN THE LAB HAVE GIVEN NORMAL RESULTS. THE SAMPLE MEASUREMENTS ARE AS FOLLOWS: SAMPLE ID: MEASUREMENT TIME AND DATE: PARAMETER: RESULT: (B)(6) 22:09 (B)(6) 2026 THB, 1.4 G/L DISCREPANT, LAB RESULT 05:30 (B)(6) 2026 THB, 96 G/L COMPARISON, LAB RESULT 22:16 (B)(6) 2026 THB, 96 G/L COMPARISON, (B)(6) 22:11 (B)(6) 2026 THB, 70 G/L COMPARISON; (B)(6) 14:44 (B)(6) 2026 THB, 0.3 G/L DISCREPANT, LAB RESULT 07:40 (B)(6) 2026 THB, 86 G/L COMPARISON, LAB RESULT 07:38 (B)(6) 2026 THB, 90 G/L COMPARISON, (B)(6) 13:46 (B)(6) 2026 THB, 85 G/L COMPARISON, (B)(6) 09:34 (B)(6) 2026 THB, 84 G/L COMPARISON; (B)(6) 11:08 (B)(6) 2026 THB, 0.1 G/L DISCREPANT, LAB RESULT 09:09 (B)(6) 2026 THB, 108 G/L COMPARISON, LAB RESULT 14:31 (B)(6) 2026 THB, 102 G/L COMPARISON, (B)(6) 17:55 (B)(6) 2026 THB, 107 G/L COMPARISON, (B)(6) 15:14 (B)(6) 2026 THB, 103 G/L COMPARISON; (B)(6) 16:28 (B)(6) 2026 THB, 1.8 G/L DISCREPANT, LAB RESULT 08:58 (B)(6) 2026 THB, 104 G/L COMPARISON, LAB RESULT 13:38 (B)(6) 2026 THB, 114 G/L COMPARISON; (B)(6) 23:08 (B)(6) 2026 THB, 12 G/L DISCREPANT, LAB RESULT 08:41 (B)(6) 2026 THB, 85 G/L COMPARISON, LAB RESULT 22:51 (B)(6) 2026 THB, 92 G/L COMPARISON, (B)(6) 15:04 (B)(6) 2026 THB, 89 G/L COMPARISON, (B)(6) 03:41 (B)(6) 2026 THB, 90 G/L COMPARISON.