Glucose HK 08057800190Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613336121283), received between Oct 5, 2021 and Sep 3, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (8 reports).

3 other recalls cover devices cleared under the same FDA submission (K191899); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591971 ↗
• MalfunctionSep 3, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50586068 ↗
• MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE GLUCOSE HK GEN.3 ASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.55 MMOL/L (6.6 MMOL/L). THE REPEAT RESULT WAS 4.53 MMOL/L (4.5 MMOL/L). THE INITIAL RESULT WAS INCONSISTENT WITH THE PATIENT'S CONDITION, PROMPTING THE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363726 ↗
• MalfunctionDec 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 303 ANALYTICAL UNIT. THE PATIENT'S FASTING GLUCOSE RESULT WAS 315 MG/DL. THE PATIENT'S HBA1C RESULT WAS 5.5 %. THE INITIAL GLUCOSE RESULT WAS QUESTIONED, AND THE SAMPLE WAS REPEATED THE NEXT DAY. ON (B)(6) 2025, THE SAMPLE WAS REPEATED, AND THE RESULT WAS 104 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794321 ↗
• MalfunctionMay 9, 2025Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH GLUCOSE HK GEN.3 (GLUC3) ASSAY ON A COBAS PURE C303 ANALYTICAL UNIT. INITIAL RESULT: 0.0122 MMOL/L (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: -0.00323 MMOL/L (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS THEN REPEATED ON A DIFFERENT COBAS PURE INSTRUMENT AT THE SAME FACILITY USING A DIFFERENT LOT NUMBER. THE 2ND AND 3RD REPEAT RESULTS WERE BOTH 0.00673 MMOL/L (ACCOMPANIED BY DATA FLAGS). THE CUSTOMER SUSPECTED AN INTERFERENCE WITH THE APPLIED TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993038 ↗
• MalfunctionNov 8, 2024Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH GLUCOSE HK GEN.3 (GLUC3) ASSAY ON A COBAS C503 ANALYTICAL UNIT WHEN COMPARED TO TEST STRIPS TESTING OF AN UNKNOWN MANUFACTURER. INITIAL RESULT: 1.70 MMOL/L BUT THE SAMPLE TUBE WAS NOT FILLED CORRECTLY AND SAMPLED FROM THE VENOUS CATHETER. 1ST REPEAT RESULT: 7.15 MMOL/L (TESTED ON TEST STRIPS OF AN UNKNOWN MANUFACTURER). THIS SAMPLE WAS FROM ANOTHER TUBE SAMPLED FROM THE VENOUS CATHETER (AND NOT CAPILLARY BLOOD). THE PATIENT'S MEDICAL TREATMENT CONTAINED DAPTOMYCIN INJECTED BY THE VENOUS CATHETER. THE PATIENT SHOWED NO SIGNS OF HYPOGLYCEMIA OR HYPERGLYCEMIA ON THAT DAY. ON 18-OCT-2024, THE SAMPLE WAS REPEATED WITH A RESULT OF 1.50 MMOL/L. THE CUSTOMER SUSPECTED AN INTERFERENCE WITH DAPTOMYCIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641834 ↗
• MalfunctionAug 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE GLUC3 GLUCOSE HK GEN.3 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBRAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER DID NOT BELIEVE THE INITIAL RESULT PROMPTING THE RERUN OF THE PATIENT SAMPLE. ON (B)(6) 2024: THE INITIAL RESULT FROM THE ANALYZER'S LINE 1 WAS 104 MG/DL. ON (B)(6) 2024: THE FIRST REPEAT RESULT FROM THE ANALYZER'S LINE 1 WAS 79.0 MG/DL. THE SECOND REPEAT RESULT FROM THE ANALYZER'S LINE 3 WAS 81.3 MG/DL. THE THIRD REPEAT RESULT FROM THE ANALYZER'S LINE 1 WAS 45.5 MG/DL WITH AN INVALIDATING DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007881 ↗
• MalfunctionMay 21, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR GLUCOSE HK GEN.3 (GLUC3) ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS < 0.2 MMOL/L. THE REPEAT RESULT WAS 5.2 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19361452 ↗
• MalfunctionDec 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH GLUCOSE HK GEN.3 ON A COBAS PRO C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 19.7 MG/DL. THE VALUE DID NOT AGREE WITH THE PATIENT'S CLINICAL STATUS, SO IT WAS REPEATED. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A GLUCOSE VALUE OF 99.9 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT AS IT MATCHED THE PATIENT'S CLINICAL STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245308 ↗
• MalfunctionNov 30, 2023Incorrect, 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 GLUCOSE HK GEN.3 ON A COBAS PRO C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 12.7 MG/DL. THE VALUE DID NOT AGREE WITH THE PATIENT'S CLINICAL STATUS, SO IT WAS REPEATED. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A GLUCOSE VALUE OF 85.6 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT AS IT MATCHED THE PATIENT'S CLINICAL STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239958 ↗
• MalfunctionOct 3, 2023Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUC3 GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL GLUCOSE RESULT WAS 21.7 MG/DL. THE CUSTOMER QUESTIONED THE LOW RESULT AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS 83.7 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860675 ↗
• MalfunctionApr 25, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED WITH THE GLUC3 (GLUCOSE HK GEN.3) ASSAY ON A COBAS PRO SAMPLE SUPPLY UNIT, SERIAL NUMBER (B)(6). THE FIRST SAMPLE INITIALLY RESULTED IN A GLUC3 VALUE OF 3651 MG/DL. A SECOND SAMPLE WAS TAKEN CLOSE IN TIME, RESULTING IN A GLUC3 VALUE OF 93 MG/DL. THE INITIAL REPORTER ALLEGED CONCERNS WITH PSEUDOHYPONATRAEMIA CAUSED BY HYPERGLYCAEMIA. THIS MEDWATCH WILL APPLY TO THE GLUC3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6). FOR INFORMATION RELATED TO THE SODIUM RESULTS. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809595 ↗
• MalfunctionMar 6, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH GLUC3 GLUCOSE HK GEN.3 ON A COBAS PRO C 503 ANALYTICAL UNIT (SERIAL NUMBER: (B)(4). EXAMPLES OF DATA WERE PROVIDED FOR TWO PATIENT SAMPLES. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST PATIENT SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 13 MG/DL AND REPEATED AS 115 MG/DL. A SECOND AFFECTED PATIENT SAMPLE WAS REPEATED AS PART OF A PRECISION TEST AND THE FOLLOWING GLUCOSE VALUES WERE OBTAINED: 92.7 MG/DL, 92.5 MG/DL, 92.5 MG/DL, 92.4 MG/DL, 92.7 MG/DL, 92.6 MG/DL, 92.5 MG/DL, 92.8 MG/DL, 92.7 MG/DL, 92.5 MG/DL, 92.5 MG/DL, 92.6 MG/DL, 92.4 MG/DL, 92.8 MG/DL, 13.9 MG/DL, 92.8 MG/DL, 92.8 MG/DL, 92.7 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491579 ↗
• MalfunctionMar 6, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUC3 GLUCOSE HK GEN.3 RESULTS FOR 3 PATIENT SAMPLES ON A COBAS PRO C 503 ANALYTICAL UNIT. FOR SAMPLE 1, THE INITIAL GLUCOSE RESULT WAS 6.74 G/L. THE REPEAT RESULT WAS 4.46 G/L. FOR SAMPLE 2, THE INITIAL GLUCOSE RESULT WAS 8.51 G/L. THE SAMPLE WAS REPEATED 5 TIMES AND THE RESULTS WERE 4.06 G/L, 4.07 G/L, 4.05 G/L, 4.03 G/L, AND 4.04 G/L. FOR SAMPLE 3, THE INITIAL GLUCOSE RESULT WAS 10.1 G/L. THE REPEAT RESULT WAS 5.1 G/L. THE REPEAT RESULTS WERE DEEMED CORRECT. CLARIFICATION ON WHETHER THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. THE REAGENT LOT NUMBER IS 64350301 AND THE EXPIRATION DATE IS 31-AUG-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486580 ↗
• MalfunctionJan 10, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE REPORTER PROVIDED QUESTIONABLE DATA FOR ONE PATIENT SAMPLE TESTED WITH CHOL2 CHOLESTEROL GEN.2 AND TEN PATIENT SAMPLES TESTED WITH GLUC3 GLUCOSE HK GEN.3 ON A COBAS C 503 ANALYTICAL UNIT. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLES WERE INITIALLY TESTED ON THE COMPLAINED C 503 ANALYZER AND THEY WERE REPEATED ON A SECOND ANALYZER. THE GLUCOSE REAGENT LOT NUMBER WAS 643503, WITH AN EXPIRATION DATE OF 31-AUG-2023. THE CHOLESTEROL REAGENT LOT NUMBER WAS 658312, WITH AN EXPIRATION DATE OF MAY 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129887 ↗
• MalfunctionNov 18, 2022Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS PRO C 503 ANALYTICAL UNIT. PATIENT 1 INITIAL BILD2 (DIRECT BILIRUBIN) RESULT WAS 0.714 MG/DL AND THE REPEAT RESULT WAS 0.0922 MG/DL. PATIENT 2 INITIAL GLUC3 (GLUCOSE) RESULT WAS 5.72 MG/DL AND THE REPEAT RESULT WAS 85.5 MG/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE DIRECT BILIRUBIN REAGENT LOT NUMBER WAS 63837501 WITH AN EXPIRATION DATE OF 31-AUG-2023. THE GLUCOSE REAGENT LOT NUMBER WAS 61404201 WITH AN EXPIRATION DATE OF 31-MAY-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826411 ↗
• MalfunctionNov 16, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH GLUC3 (GLUCOSE HK GEN.3) ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A GLUC3 VALUE OF 0.6 MMOL/L AND REPEATED AS 5.6 MMOL/L. THE GLUC3 REAGENT LOT WAS 62948701 WITH AN EXPIRATION DATE OF 31-JUL-2023. IT IS NOT KNOWN WHICH RESULT IS DEEMED CORRECT. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803783 ↗
• MalfunctionApr 26, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH GLUC3 GLUCOSE HK GEN.3 ON TWO COBAS PRO C503 MODULES. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 3.68 MMOL/L ON THE FIRST C503 SYSTEM (SERIAL NUMBER (B)(4)) AND THIS VALE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE CLINICIAN. THE CLINICIAN ASKED FOR A NEW SAMPLE TO BE COLLECTED FROM THE PATIENT AND TESTED AS THE RESULT WAS NOT CONSISTENT WITH THE PATIENT'S CLINICAL STATUS AND THE PATIENT HAD A CAPILLARY GLUCOSE RESULT OF 1.2 MMOL/L. THE SAMPLE WAS REPEATED ON A SECOND C503 ANALYZER (SERIAL NUMBER UNKNOWN) AND THE RESULT WAS IDENTICAL TO THE FIRST VALUE. A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A GLUCOSE VALUE OF 1.0 MMOL/L WHEN TESTED ON THE FIRST C503 SYSTEM. A NEW CAPILLARY SAMPLE COLLECTED FROM THE PATIENT RESULTED IN A GLUCOSE VALUE OF 1.1 MMOL/L. THE COMPLAINED SAMPLE WAS LATER REPEATED ON THE FIRST C503 SYSTEM ON (B)(6) 2022, RESULTING IN A GLUCOSE VALUE OF 3.99 MMOL/L. THE GLUCOSE REAGENT LOT NUMBER AND EXPIRATION DATE USED FOR THE FIRST MEASUREMENT WERE REQUESTED, BUT NOT PROVIDED. THE SECOND MEASUREMENT OF THE SAMPLE PERFORMED ON (B)(6) 2022 WAS TESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14208533 ↗
• MalfunctionOct 5, 2021Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FOR ONE PATIENT TESTED ON A COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE PATIENT HAD TWO URINE SAMPLES TESTED FOR GLUCOSE. THE PATIENT'S QUESTIONABLE GLUCOSE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING WITH BOTH SAMPLES. THE "BIOLOGIST DISCUSSED ABOUT THESE CURIOUS INCREASING GLUCOSE RESULTS FROM URINE OF THIS PATIENT WITH HIS PHYSICIAN." THE PATIENT'S FIRST SAMPLE HAD AN INITIAL GLUCOSE RESULT OF "AROUND 1000" MG/DL. "AROUND ONE HOUR LATER," THE PATIENT'S FIRST REPEAT GLUCOSE RESULT WAS "AROUND 2000" MG/DL. THE FIRST SAMPLE WAS TESTED "LATER" AND THE PATIENT'S SECOND REPEAT GLUCOSE RESULT WAS "AROUND 2500" MG/DL. THE PATIENT'S SECOND SAMPLE HAD AN INITIAL GLUCOSE RESULT OF "AROUND 800" MG/DL. THE PATIENT'S REPEAT GLUCOSE RESULT "LATER" WAS "AROUND 1200 MG/DL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12575930 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191899. One submission often covers many models, so check the product and lot details in each record.

• Z-1476-2026 · Jan 20, 2026 · Open, Classified
  cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected As
• Z-0755-2021 · Dec 8, 2020 · Open, Classified
  Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 056414
• Z-0752-2021 · Nov 23, 2020 · Terminated
  cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use