Glucose HK Gen3 5168791190Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04015630925025), received between Dec 5, 2022 and Jan 3, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS 570 MG/DL. THE FIRST REPEAT RESULT WAS 123 MG/DL. THE SECOND REPEAT RESULT WAS 124 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AS IT DID NOT MATCH THE PATIENT'S HISTORY. THE REPEAT RESULTS WERE DEEMED TO BE THE CORRECT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067120 ↗
• MalfunctionOct 30, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED A HIGH GLUC3 ASSAY RESULT FOR 1 PATIENT'S URINE SAMPLE TESTED ON A COBAS 8000 C 702 MODULE. THE URINE RESULTS WERE >ABS "SEVERAL" TIMES. WHEN DILUTED X10, THE URINE RESULT WAS 243.4 MMOL/L. THE RESULT FROM A COMPETITOR URINE STRIP WAS 111 MMOL/L. THE GLUCOSE RESULT FROM THE SERUM SAMPLE WAS 6.1 MMOL/L. THE CUSTOMER IS WONDERING ABOUT POSSIBLE INTERFERENCES THAT COULD AFFECT THE URINE GLUCOSE RESULT AS IT IS NOT CONSISTENT WITH THE SERUM GLUCOSE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18028330 ↗
• MalfunctionSep 14, 2023Contamination; Contamination

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH GLUC3 (GLUCOSE) ON A COBAS 8000 C702 MODULE. NO UNITS OF MEASURE WERE PROVIDED. THE FIRST SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 1.02 AND IT REPEATED AS 6.48. THE SECOND SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 2.36 AND IT REPEATED AS 5.48.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746575 ↗
• MalfunctionAug 31, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUC3 GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C702 MODULE. THE INITIAL GLUCOSE RESULT FROM MODULE A WAS 85.7 MG/DL. THE SAMPLE WAS REPEATED ON MODULE B AND THE RESULT WAS 56.4 MG/DL. BOTH RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663365 ↗
• MalfunctionAug 4, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE GLUC3 GLUCOSE HK GEN.3 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT WAS REPORTED TO A SATELLITE LABORATORY. THE SATELLITE LABORATORY STAFF QUESTIONED THE RESULT AS THE PATIENT HAD NORMAL CAPILLARY GLYCEMIA. THE SAMPLE WAS THE PATIENT'S BASELINE SAMPLE FOR GLUCOSE LOAD ASSESSMENT. ON 05-JUL-2023, THE INITIAL RESULT WAS 124.8 MG/DL THE FIRST REPEAT RESULT WAS 174.9 MG/DL. A RESULT OF 174 MG/DL WAS REPORTED TO THE SATELLITE LABORATORY. ON 06-JUL-2023, THE SECOND REPEAT RESULT WAS 175.4 MG/DL. THE THIRD REPEAT RESULT WAS 72.9 MG/DL. THE FOURTH REPEAT RESULT WAS 74.3 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17461410 ↗
• MalfunctionMay 16, 2023Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER STATED, THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE GLUC3 (GLUCOSE HK GEN. 3), ASSAY ON A COBAS 8000 COBAS C 701 MODULE, SERIAL NUMBER (B)(4). THE SAMPLE INITIALLY RESULTED IN A GLUC3 VALUE OF 0.00 MMOL/L, AND REPEATED AS 5.23 MMOL/L. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16941728 ↗
• MalfunctionApr 10, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE GLUC HK GEN.3 (GLUCOSE) RESULTS FOR MULTIPLE PATIENTS RUN ON A COBAS 8000 C7012 ANALYZER WITH (B)(4). THE INITIAL REPORTER PROVIDED RESULTS FOR 2 SAMPLES. FOR SAMPLE 1 THE INITIAL GLUCOSE WAS 11 MG/DL WITH A REPEAT OF 95 MG/DL. SAMPLE 2 HAD AN INITIAL GLUCOSE OF 23 MG/DL WITH A REPEAT OF 102 MG/DL. SAMPLE 2 WAS RERUN IN THE SAME PRIMARY TUBE WITHOUT EXAMINATION OR RECENTRIFUGATION. THE INITIAL REPORTER STATED THE ISSUE IS RECURRENT BUT RANDOM. SHE ALSO SAID THAT THE SAMPLES ARE STORED AT ROOM TEMPERATURE, 26-31C, AND THAT FIBRIN HAS BEEN OBSERVED IN SOME SAMPLE TUBES. SHE NOTED THAT A WATER HOSE FROM THE OSMOSIS UNIT WAS CONTAMINATED. NO INCORRECT RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709758 ↗
• MalfunctionMar 22, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUC3 GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT URINE SAMPLE ON A COBAS 8000 COBAS C 701 MODULE. THE INITIAL GLUC3 RESULTS WITH AND WITHOUT AUTO-DILUTION WERE ACCOMPANIED BY A FLAG INDICATING THE VALUES WERE ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY. THIS PROMPTED THE CUSTOMER TO PERFORM A MANUAL 1:5 DILUTION OF THE PATIENT SAMPLE. THE MANUAL 1:5 DILUTION RESULT WAS 18.45 G/L. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON ANOTHER C701 ANALYZER. THE SAMPLE WAS RE-CENTRIFUGED AND THE RESULT WITHOUT DILUTION WAS 3.3 G/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER'S ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594914 ↗
• MalfunctionFeb 20, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE GLUC3 GLUCOSE HK GEN.3 RESULTS FROM FIVE PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS C 701 MODULE WITH SERIAL NUMBER (B)(4). THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2023: SAMPLE 1 HAD AN INITIAL RESULT OF 0.019 MMOL/L. THE FIRST REPEAT RESULT WAS 0.879 MMOL/L. THE THIRD REPEAT RESULT WAS 0.86 MMOL/L. ON (B)(6) 2023 : THE REPORTER HAD THE SAME ISSUE FOR FOUR PATIENT SAMPLES. THE REPORTER WAS NOT ABLE TO PROVIDE THE EXACT RESULTS BUT STATED THAT THE INITIAL RESULTS WERE APPROXIMATELY 0.02 MMOL/L AND THE REPEAT RESULTS WERE APPROXIMATELY 1 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405298 ↗
• MalfunctionDec 5, 2022Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUC HK GEN.3 (GLUCOSE) RESULTS FROM THE COBAS 8000 COBAS C 701 MODULE. ONE EXAMPLE WAS PROVIDED OF AN INITIAL RESULT OF 16.8 MG/DL AND A REPEAT RESULT OF 129.2 MG/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED CORRECT. THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914976 ↗