Tina-quant Hemoglobin A1cDx Gen.3 08056668190Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07613336120927), received between Nov 4, 2022 and May 13, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “High Test Results” (23 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM ONE PATIENT TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN.3 ON A COBAS C 503 ANALYTICAL UNIT. THE RESULTS ALLEGEDLY DO NOT MATCH THE PATIENT'S CLINICAL CONDITION. THE PHYSICIAN EXPECTED LOWER PATIENT RESULTS BASED ON RESULTS OBTAINED WITH A CONTINUOUS BLOOD MONITOR (CBM) DEVICE. THE PATIENT'S CONTINUOUS BLOOD MONITOR SHOWS A GLUCOSE MANAGEMENT INDICATOR RESULT BELOW 7 %. THE PATIENT'S AVERAGE CBM GLUCOSE IS 145 MG/DL. THE CBM IS REPLACED EVERY 15 DAYS AND IT CORRECTLY PLACED. ON (B)(6) 2026, A FIRST SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN HBA1C VALUE OF 7.7%. ON (B)(6) 2026, A SECOND SAMPLE COLLECTED FROM THE PATIENT WAS TESTED TWICE, EACH TIME RESULTING IN AN HBA1C VALUE OF 8.2 %. ON (B)(6) 2026, A THIRD SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN HBA1C VALUE OF 7.9 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159408 ↗
• MalfunctionJan 30, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 6.9%, AND THE REPEATED RESULT WAS 6.0%. PATIENT 2: THE INITIAL RESULT WAS 8.0%, AND THE REPEATED RESULT WAS 6.9%. THE SAMPLES WERE REPEATED BECAUSE THE INITIAL RESULTS WERE HIGH. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE, AND THEY WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24224633 ↗
• MalfunctionDec 15, 2025Incorrect Measurement; High Test Results; Insufficient Device Problem Information; Non Reproducible Results; Incorrect Measurement; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE HBA1C ASSAY ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF (B)(4). A NEW SAMPLE COLLECTED FROM THE PATIENT HAD AN HBA1C VALUE THAT TRIGGERED A LABORATORY DELTA CHECK ALERT BASED ON THE RESULT FROM THE COMPLAINED SAMPLE. DUE TO THIS, THE SAMPLE WAS REPEATED. THE COMPLAINED SAMPLE WAS REPEATED, RESULTING IN AN HBA1C VALUE OF (B)(4). THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801327 ↗
• MalfunctionDec 3, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULT FROM THE COBAS C 503 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 6.3%, AND THE REPEAT RESULT WAS REPORTED TO BE NORMAL. THE EXACT RESULT WAS NOT PROVIDED. THE PATIENT COMPLAINED ABOUT THE INITIAL RESULT AND WENT TO ANOTHER LABORATORY. THE NEW SAMPLE RESULT WAS 5.1%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706716 ↗
• MalfunctionJul 7, 2025Chemical Problem; Chemical Problem

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN.3 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 6.4 %. A DOCTOR QUESTIONED THE RESULT, SO THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 5.7 % AND THIS VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412976 ↗
• MalfunctionMay 13, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN.3 RESULT FROM THE COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.46%, AND THE REPEAT RESULT WAS 5.81%. THE REPEAT RESULT WAS DEEMED TO BE CORRECT BECAUSE IT MATCHED THE PATIENT'S HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008423 ↗
• MalfunctionMay 8, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT THE INITIAL RESULT WAS 6.0%. THE REPEAT RESULT WAS 4.9%. THE REPEAT RESULT WAS DEEMED CORRECT. THE PHYSICIAN DEEMED THE INITIAL RESULT TOO HIGH FOR THE PATIENT'S CLINICAL PICTURE, PROMPTING THE PATIENT'S SAMPLE TO BE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984475 ↗
• MalfunctionNov 14, 2024High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 5 PATIENTS' SAMPLES TESTED WITH HBA1C ON A COBAS PURE C303 ANALYTICAL UNIT. SAMPLE 1 (PATIENT 1) WAS TESTED ON 26-SEP-2024: INITIAL RESULT: 10.5 % (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 6.11 %. THIS SAMPLE WAS A WHOLE BLOOD SAMPLE. SAMPLE 2, SAMPLE 3, SAMPLE 4, AND SAMPLE 5 WERE TESTED ON 14-OCT-2024: SAMPLE 2 (PATIENT 2): INITIAL RESULT: 8.00 %. REPEAT RESULT: 5.22 %. SAMPLE 3 (PATIENT 3): INITIAL RESULT: 6.88 %. REPEAT RESULT: 4.70 %. SAMPLE 4 (PATIENT 4): INITIAL RESULT: 7.49 %. REPEAT RESULT: 5.14 %. SAMPLE 5 (PATIENT 5): INITIAL RESULT: 7.87 %. REPEAT RESULT: 4.96 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689392 ↗
• MalfunctionOct 15, 2024High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT HBA1C RESULTS FOR AROUND 50 PATIENTS' SAMPLES TESTED ON A COBAS C503 ANALYTICAL UNIT WHEN COMPARED TO A DIFFERENT ANALYZER. DISCREPANT HBA1C RESULTS FOR 1 PATIENT SAMPLE WERE PROVIDED. INITIAL RESULT: 7%. THE SAME SAMPLE WAS REPEATED ON A DIFFERENT INSTRUMENT AND THE REPEAT RESULT WAS 10%. IT IS UNCLEAR IF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THIS INFORMATION WAS REQUESTED BUT IT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20451806 ↗
• MalfunctionJul 17, 2024Mechanical Problem; High Test Results; Mechanical Problem; High Test Results

  WE RECEIVED AN ALLEGATION OF DISCREPANT HIGH RESULTS FOR 45 PATIENT SAMPLES TESTED FOR TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS C 503 ANALYTICAL UNIT BETWEEN (B)(6) 2024. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE CLIENT COMPLAINED. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS. REAGENT LOT 733771, EXPIRATION 31-OCT-2024 WAS PUT ON THE ANALYZER ON (B)(6) 2024. REAGENT LOT 765168, EXPIRATION 31-MAR-2025 WAS PUT ON THE ANALYZER ON (B)(6) 2024. REAGENT LOT 779801, EXPIRATION 30-APR-2025 WAS PUT ON THE ANALYZER ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19763723 ↗
• MalfunctionJul 12, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS PURE C 303 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 10.9 %. THE VALUE WAS QUESTIONED BY A PHYSICIAN AS THE RESULT DID NOT CORRELATE WITH THE PATIENT'S CLINICAL STATE. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN AN HBA1C VALUE OF 5.09 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733001 ↗
• MalfunctionJul 2, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 8.14% AND THE REPEATED RESULT WAS 5.35%. PATIENT 2: THE INITIAL RESULT WAS 7.43% AND THE REPEATED RESULT WAS 5.54%. THE SAMPLES WERE REPEATED DUE TO THE RESULTS NOT CORRELATING WITH THE PATIENTS' GLUCOSE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19659477 ↗
• MalfunctionJun 24, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS PURE C 303 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 4.42 %. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 6.61 %. THE SECOND SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 4.68 % ON (B)(6) 2024. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 7.28 % ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601016 ↗
• MalfunctionMar 28, 2024Incorrect Measurement; High Test Results; Non Reproducible Results; Incorrect Measurement; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 7.1 %. THE PATIENT ASKED FOR A REPEAT OF THE SAMPLE. THE SAMPLE WAS REPEATED, RESULTING IN AN HBA1C VALUE OF 5.78 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997223 ↗
• MalfunctionMar 7, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 RESULTS FROM SIX PATIENT SAMPLES TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE REPORTER WAS ABLE TO PROVIDE ONE PATIENT SAMPLE WITH DISCREPANT RESULTS: THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE INITIAL RESULT WAS 7%. THE REPEAT RESULT WAS 6%. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18854834 ↗
• MalfunctionFeb 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS PURE C 303 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 7.91 % AND IT REPEATED AS 5.44 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720114 ↗
• MalfunctionNov 17, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 (HBA1C) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 7.81 % AND IT REPEATED AS 5.45 %. THE SECOND SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 7.34 % AND IT REPEATED AS 5.77 %. THE THIRD SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 5.95 % AND IT REPEATED AS 5.40 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158758 ↗
• MalfunctionNov 6, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 7.65 %. THE REPEAT RESULT WAS 5.58%. THE REPEAT RESULT WAS BELIEVED TO BE THE TRUE RESULT BASED ON THE PATIENT'S HISTORY AND THE GLUCOSE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072463 ↗
• MalfunctionOct 3, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE A1C-2 TINA-QUANT HEMOGLOBIN A1C GEN.2 AND GLUC3 GLUCOSE HK GEN.3 RESULTS FOR 4 PATIENT SAMPLES ON A COBAS PRO C 503 ANALYTICAL UNIT. ON 04-SEP-2023, SAMPLE 1 HAD AN INITIAL A1C-2 RESULT OF 6.6%. THE DOCTOR QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY AND THE SAMPLE WAS REPEATED. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 5.39% AND 5.49%. THE RESULT OF 5.49% WAS DEEMED CORRECT. ON 07-SEP-2023, SAMPLE 2 HAD AN INITIAL A1C-2 RESULT OF 6.31%. THE SAMPLE WAS REPEATED AND THE RESULT WAS 5.29%. ON 15-SEP-2023, SAMPLE 3 HAD AN INITIAL GLUCOSE RESULT OF 30 MG/DL. THE REPEAT RESULT WAS CONSIDERED "NORMAL." THE EXACT REPEAT RESULT WAS NOT PROVIDED. ON 15-SEP-2023, SAMPLE 4 HAD AN INITIAL GLUCOSE RESULT OF 22 MG/DL. THE REPEAT RESULT WAS CONSIDERED "NORMAL." THE EXACT REPEAT RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861833 ↗
• MalfunctionSep 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 ON A COBAS PRO C 503 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN AN HBA1C RESULT OF 8.4 %. A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN HBA1C VALUE OF 5.5 %. THE FIRST SAMPLE WAS THEN REPEATED ON (B)(6) 2023, RESULTING IN A VALUE OF 5.5 %. THE SECOND PATIENT SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 9.53 % AND IT REPEATED AS 7.34 %. THE THIRD PATIENT SAMPLE RESULTED IN THE FOLLOWING HBA1C VALUES ON (B)(6) 2023: 6.39 %, 9.36 %, 7.34 %, 8.19 %, 7.19 %, 6.95 %, 8.64 %, 12.5 %, 9.94 %, 12.2 %, AND 7.05 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808529 ↗
• MalfunctionSep 18, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE HBA1C RESULTS FROM ABOUT 7 TO 10 PATIENT SAMPLES TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULTS WERE REPORTED TO THE PATIENTS. THE REPORTER STATED THAT THE RESULTS OF THE 7-10 SAMPLES WERE HIGH - BETWEEN 8-10%. THE REPORTER STATED THAT THE PATIENTS ALLEGED THAT THEY HAVE A NON-DIABETIC HISTORY AND THAT THEY RETESTED BY THEMSELVES AT OTHER SITES AND THE RESULTS WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17763587 ↗
• MalfunctionMar 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 20 PATIENTS' SAMPLES TESTED WITH THE HBA1C ASSAY ON COBAS PRO 1 C503 ANALYTICAL UNIT SERIAL NUMBER (B)(4) COMPARED TO PRO 2 SERIAL NUMBER (B)(4). ON (B)(6) 2023 THE CUSTOMER RAN THE PATIENTS' SAMPLES ON COBAS PRO 1. ON (B)(6) 2023 THE PATIENTS' SAMPLES WERE RERUN ON COBAS PRO 2. THEN LATER THAT DAY THE CUSTOMER CHANGED THE PROBE AND RERAN THE PATIENTS' SAMPLES ON COBAS PRO 1. REFER TO THE ATTACHED PATIENTS' DATA. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE CUSTOMER IS IN THE PROCESS OF CORRECTING THEM AFTER THEY GOT REPEATED. THE REPEAT RESULTS DEEMED TO BE CORRECT. THE CUSTOMER STATED THAT COBAS PRO 1 WAS CALIBRATED ON 9-FEB-2023 BUT WHEN THEY LOADED A NEW PACK, THE CALIBRATION REVERTED TO THE LOT CALIBRATION PERFORMED ON 27-JAN-2023. THE CUSTOMER ALSO STATED THAT THEY NOTICED A LOT OF BUILD UP ON THE SAMPLE PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16581701 ↗
• MalfunctionJan 10, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HEMOGLOBIN A1C RESULTS FROM THE COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE CUSTOMER ESTIMATED 500 PATIENT RESULTS HAD TO BE CORRECTED. ONE REPRESENTATIVE EXAMPLE WAS PROVIDED OF AN ORIGINAL RESULT OF 6.9% AND A REPEAT RESULT OF 5.2%. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELOVED CORRECTED. ONE SURGERY WAS CANCELED AND A MEDICATION NOT NEEDED WAS ORDERED BUT NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129886 ↗
• MalfunctionJan 4, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE A1CX3 (TINA-QUANT HEMOGLOBIN A1CDX GEN.3) RESULTS FOR FOUR PATIENT SAMPLES TESTED ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2022: SAMPLE 1 THE INITIAL RESULT WAS 17.4 %. THE REPEAT RESULT WAS 23.9 %. SAMPLE 2 THE INITIAL RESULT WAS 9.18 %. THE REPEAT RESULT WAS 7.5 %. SAMPLE 3 THE INITIAL RESULT WAS 7.01 %. THE REPEAT RESULT WAS 6.03 %. FOR SAMPLE 3, THE REPORTER DETECTED THAT THE GLUCOSE RESULT DID NOT COINCIDE WITH THE HBA1C RESULT WHICH PROMPTED THE RERUN OF THE SAMPLE. ON (B)(6) 2022, THE FIELD SERVICE REPRESENTATIVE (FSR) CHANGED ONE OF THE SOLENOID VALVES (SV). ON (B)(6) 2022, THE FOLLOWING QUESTIONABLE RESULTS WERE OBTAINED: SAMPLE 4 THE INITIAL RESULT WAS 6.08 %. THE REPEAT RESULT WAS 7.1 %. SAMPLE 5 THE INITIAL RESULT WAS 7.02 %. THE REPEAT RESULT WAS 5.5 %. SAMPLE 6 THE INITIAL RESULT WAS 7.01 %. THE REPEAT RESULT WAS 6.03 %. SAMPLE 7 THE INITIAL RESULT WAS 8.03 %. THE REPEAT RESULT WAS 5.7 %. ON (B)(6) 2022, THE FIELD SERVICE REPRESENTATIVE (FSR) CHANGED THE PIPETTE AND PRINTED CIRCUIT BOARD (PCB). HE ALSO ADJUSTED THE ULTRASONIC AGITATORS AS THE FREQUENCIES DID NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094840 ↗
• MalfunctionDec 20, 2022False Positive Result; High Test Results; False Positive Result; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH A1C-3 TINA-QUANT HEMOGLOBIN A1C GEN.3 ON A COBAS C 503 ANALYTICAL UNIT. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN HBA1C VALUE OF 12.9 % AND REPEATED AS 5.64 %. THE HBA1C REAGENT LOT NUMBER WAS 62958201, WITH AN EXPIRATION DATE OF 31-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016153 ↗