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Glucose HK 4404483190Recalls & reported problems

Roche Diagnostics GmbH · Class 2

All models of Glucose HK (3)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Roche Diagnostics Glucose HK assay is a lab test used on cobas analyzers to measure glucose in blood and urine samples. The 28 reports mostly describe glucose readings that did not repeat — results that came back very low, very high, or different when the same sample was tested again, sometimes on another analyzer or module. No deaths and no injuries are reported. No recalls name this assay.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
30
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 04015630920297), received between Jul 26, 2018 and Aug 31, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (14 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.

Reports received per month

Nov 2023: 2 reportsDec 2023: 3 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 2 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 2 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 2 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Low Test Results14
  • Non Reproducible Results13
  • High Test Results7
  • Incorrect, Inadequate or Imprecise Result or Readings3
  • Incorrect Measurement1
  • Insufficient Device Problem Information1
  • Material Integrity Problem1
  • No Apparent Adverse Event1

Patient problems

  • No Clinical Signs, Symptoms or Conditions28
  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 31, 2026High Test Results

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50531326 ↗
  • MalfunctionAug 14, 2026Insufficient Device Problem Information; Non Reproducible Results; Wrong Label

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50256286 ↗
  • MalfunctionFeb 12, 2026Incorrect Measurement

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SERUM SAMPLE ON A COBAS 4000 C311 STAND ALONE SYSTEM AND 7 PATIENT URINE SAMPLES COMPARED TO A COMPETITOR ANALYZER. SAMPLE 1 HAD AN INITIAL SERUM GLUCOSE RESULT OF 129.7 MG/DL. THE REPEAT RESULT WAS 85.6 MG/DL. SAMPLE 2 HAD A URINE GLUCOSE RESULT OF 6.97 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS 100 MG/DL. SAMPLE 3 HAD A URINE GLUCOSE RESULT OF 5.66 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS 100 MG/DL. SAMPLE 4 HAD A URINE GLUCOSE RESULT OF 2.42 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS 100 MG/DL. SAMPLE 5 HAD A URINE GLUCOSE RESULT OF 1.51 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS 100 MG/DL. SAMPLE 6 HAD A URINE GLUCOSE RESULT OF 7.98 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS 100 MG/DL. SAMPLE 7 HAD A URINE GLUCOSE RESULT OF 716 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS >100 MG/DL. SAMPLE 8 HAD A URINE GLUCOSE RESULT OF 2.24 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS 100 MG/DL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24324885 ↗
  • MalfunctionJan 28, 2026High Test Results

    THE INITIAL REPORTER RECEIVED QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS INTEGRA 400 PLUS. THE INITIAL RESULT FROM THE ANALYZER WAS 408.4 MG/DL WITH A DATA FLAG. THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 409.2 MG/DL THE SECOND REPEAT RESULT FROM THE ANALYZER WAS 408.4 MG/DL. THE RESULT FROM A FREESTYLE LITE GLUCOMETER WAS 240 MG/DL. THE TIME INTERVAL BETWEEN THE TESTS WAS NOT PROVIDED. THE REPORTER AND THE DOCTOR QUESTIONED THE RESULT BECAUSE IT DID NOT MATCH THE PREVIOUS PATIENT'S HISTORY IN THE CHART. THE DOCTOR USED THE RESULT FROM THE GLUCOMETER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24200759 ↗
  • MalfunctionJan 16, 2026Low Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 0.26 MMOL/L. THE RESULT WAS 4.79 MMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24095020 ↗
  • MalfunctionSep 3, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FOR 2 PATIENT PLASMA SAMPLES ON A COBAS 6000 C (501) MODULE. THE CUSTOMER WAS PROMPTED TO REPEAT THE INITIAL RESULTS AS THEY HAVE PROTOCOLS TO REPEAT ALL CIRITICAL VALUES. FOR SAMPLE 1, THE INITIAL GLUCOSE RESULT WAS 19 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 89 MG/DL. FOR SAMPLE 2, THE INITIAL GLUCOSE RESULT WAS 39 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 119 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22955111 ↗
  • MalfunctionMay 27, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FROM THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 14 MG/DL. MEDICATION WAS PROVIDED TO RAISE THE PATIENT¿S GLUCOSE BY AN ESTIMATED 100 POINTS. THE REPEAT RESULT WAS 470 MG/DL. A NEW SAMPLE WAS DRAWN FROM THE PATIENT APPROXIMATELY 30 MINUTES LATER, AND THE RESULT WAS 581 MG/DL. THE RESULTS OF 470 MG/DL AND 581 MG/DL WERE BELIEVED TO BE CORRECT AS THEY WERE CONSISTENT WITH THE PATIENT¿S HEALTH AND HISTORY OF HIGH GLUCOSE RESULTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22087080 ↗
  • MalfunctionApr 23, 2025Low Test Results; Material Integrity Problem; Low Test Results; Material Integrity Problem

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS OCCURRING WITH MULTIPLE ASSAYS FROM THE COBAS 6000 C501 MODULE. GLUCOSE HK GEN.3 RESULTS WERE PROVIDED FOR 1 PATIENT THAT IS A REPORTABLE MALFUNCTION. THE INITIAL RESULT WAS 1.35 MMOL/L, AND THE REPEAT RESULT WAS 8.24 MMOL/L. THE INITIAL RESULT WAS REPEATED BECAUSE THE DOCTOR AND PATIENT QUESTIONED IT, AS IT DID NOT MATCH THE CLINICAL PICTURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21893950 ↗
  • MalfunctionOct 1, 2024No Apparent Adverse Event; Non Reproducible Results; No Apparent Adverse Event; Non Reproducible Results

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 6 PATIENTS' SAMPLES TESTED WITH GLUC HK GEN.3 (GLUC3) ASSAY ON A COBAS 6000 C501 (UL) V ANALYZER. DISCREPANT RESULTS FOR 1 PATIENT PLASMA SAMPLE WERE PROVIDED AS AN EXAMPLE. INITIAL RESULT: 93 MG/DL. VALIDATING THE ANALYZER AFTER A SERVICE VISIT PROMPTED THE REPEAT OF THE SAMPLE. ON (B)(6) 2024: REPEAT RESULT: 60 MG/DL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20346731 ↗
  • MalfunctionJul 24, 2024Non Reproducible Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR 3 PATIENT SAMPLES TESTED FOR COBAS INTEGRA GLUCOSE HK GEN. 3 ON A COBAS INTEGRA 400 PLUS ANALYZER. PATIENT 1 INITIAL RESULT WAS 19 MG/DL. SINCE THE RESULT WAS LOW, THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 109 MG/DL. ON (B)(6)2024 PATIENT 2 INITIAL RESULT WAS 4.0 MG/DL. THE REPEAT RESULT WAS 86 MG/DL. ON (B)(6)2024 PATIENT 3 INITIAL RESULT WAS 1.0 MG/DL. THE REPEAT RESULT WAS 86 MG/DL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19820347 ↗
  • MalfunctionApr 23, 2024Non Reproducible Results; Non Reproducible Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUC3 GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 4000 C311 STAND ALONE SYSTEM. THE INITIAL GLUCOSE RESULT WAS 120 MG/DL. THE CUSTOMER QUESTIONED THE HIGH RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT AND WAS PROMPTED TO REPEAT THE SAMPLE. THE CUSTOMER ALSO CHANGED THE REAGENT PACK PRIOR TO SAMPLE REPETITION. THE SAMPLE WAS REPEATED AND THE RESULT WAS 82 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19166618 ↗
  • MalfunctionApr 4, 2024Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

    THE INITIAL REPORTER QUESTIONED A HIGH RESULT NOT CORRESPONDING TO THE CLINICAL STATUS FOR 1 PATIENT SAMPLE TESTED FOR COBAS INTEGRA GLUCOSE HK GEN. 3 (GLUC3) ON A COBAS C 311 ANALYZER. THE CUSTOMER ALLEGED THE RESULT WAS "TOO HIGH." THE SPECIFIC RESULT WAS NOT PROVIDED. ADDITIONAL EVENT DETAILS WERE REQUESTED BUT HAVE NOT BEEN PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19043062 ↗
  • MalfunctionMar 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM SAMPLE TESTED WITH SODIUM (NA) TEST AND 1 PATIENT'S SERUM SAMPLE TESTED WITH NA TEST AND GLUCOSE HK GEN.3 (GLUC3) ASSAY ON A COBAS 6000 C501 ANALYZER. SAMPLE 1: NA: INITIAL RESULT: 165 MMOL/L. REPEAT RESULT: 140 MMOL/L. SAMPLE 2: NA: INITIAL RESULT: 150 MMOL/L. REPEAT RESULT: 141 MMOL/L. GLUC3: INITIAL RESULT: 42 MG/DL. REPEAT RESULT: 106 MG/DL. THE MEDICAL PERSONNEL QUESTIONED THE INITIAL RESULTS AND REQUESTED THE SAMPLES BE REPEATED. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18913316 ↗
  • MalfunctionJan 31, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH COBAS INTEGRA GLUCOSE HK GEN. 3 ON A COBAS INTEGRA 400 PLUS. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 187.1 MG/DL. THE CLINICIAN QUESTIONED THE RESULT SINCE THE PATIENT DID NOT HAVE DIABETES. THE SAMPLE WAS REPEATED, RESULTING IN A GLUCOSE VALUE OF 94.4 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18615712 ↗
  • MalfunctionDec 19, 2023Low Test Results; Low Test Results

    THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUCOSE (GLUC HK GEN.3) RESULT FROM THE COBAS 6000 C 501. THE INITIAL RESULT WAS 9 MG/DL WITH A DATA FLAG AND THE REPEAT RESULT WAS 72 MG/DL. THE REPEAT RESULT FROM ANOTHER COBAS C501 WAS 74 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT FROM THE OTHER ANALYZER WAS BELIEVED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18359804 ↗
  • MalfunctionDec 19, 2023Non Reproducible Results; Non Reproducible Results

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH MULTIPLE ASSAYS ON A COBAS 6000 C501 ANALYZER WHEN COMPARED TO A DIFFERENT COBAS 6000 C501 ANALYZER. THE AFFECTED ASSAYS WERE SODIUM (NA), CHLORIDE (CL), GLUCOSE HK GEN.3 (GLUC3), CALCIUM GEN.2 (CA2), CHOLESTEROL GEN.2 (CHOL2), AND BILIRUBIN TOTAL GEN.3 (BILT3). NA: INITIAL RESULT: 119 MMOL/L. 1ST REPEAT RESULT: 140 MMOL/L. 2ND REPEAT RESULT: 135 MMOL/L (TESTED ON ANOTHER C501). CL: INITIAL RESULT: 87.2 MMOL/L. 1ST REPEAT RESULT: 103.9 MMOL/L. 2ND REPEAT RESULT: 105 MMOL/L (TESTED ON ANOTHER C501). GLUC3: INITIAL RESULT: 60 MG/DL. REPEAT RESULT: 86 MG/DL (TESTED ON ANOTHER C501). CA2: INITIAL RESULT: 7.41 MG/DL. REPEAT RESULT: 9.61 MG/DL (TESTED ON ANOTHER C501). CHOL2: INITIAL RESULT: 75 MG/DL. REPEAT RESULT: 158 MG/DL (TESTED ON ANOTHER C501). BILT3: INITIAL RESULT: 0.62 MG/DL. REPEAT RESULT: 0.92 MG/DL (TESTED ON ANOTHER C501). THE INITIAL NA RESULT WAS QUESTIONED. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULTS WAS ISSUED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18356691 ↗
  • MalfunctionDec 18, 2023Low Test Results; Low Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUC3 GLUCOSE HK GEN.3, HDLC3 HDL-CHOLESTEROL PLUS 3RD GENERATION, GEN.2 ISE INDIRECT FOR NA AND K RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C (501) MODULE. THE INITIAL GLUCOSE RESULT WAS 108 MG/DL, THE INITIAL HDL RESULT WAS 12 MG/DL, THE INITIAL K RESULT WAS 6.00 MMOL/L, AND THE INITIAL NA RESULT WAS 160 MMOL/L. THE CUSTOMER NOTICED DATA FLAGS ON SOME OF THE OTHER TEST RESULTS WHICH PROMPTED THEM TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE REPEAT GLUCOSE RESULT WAS 87 MG/DL, THE REPEAT HDL RESULT WAS 52 MG/DL, THE REPEAT K RESULT WAS 4.34 MMOL/L, AND THE REPEAT NA RESULT WAS 140 MMOL/L.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18346980 ↗
  • MalfunctionNov 20, 2023Low Test Results; Low Test Results

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUC3 GLUCOSE HK GEN.3 RESULTS FOR 3 PATIENT SAMPLES ON A COBAS 6000 C (501) MODULE. THE CUSTOMER WAS PROMPTED THE REPEAT THE SAMPLES AS THE INITIAL RESULTS SEEMED TOO LOW. FOR SAMPLE 1, THE INITIAL GLUCOSE RESULT WAS 3 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER C501 ANALYZER AND THE RESULT WAS 215 MG/DL. FOR SAMPLE 2, THE INITIAL GLUCOSE RESULT WAS 3 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER C501 ANALYZER AND THE RESULT WAS 298 MG/DL. FOR SAMPLE 3, THE INITIAL GLUCOSE RESULT WAS 2 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER C501 ANALYZER AND THE RESULT WAS 115 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18177514 ↗
  • MalfunctionNov 15, 2023Low 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 COBAS INTEGRA GLUCOSE HK GEN. 3 ON A COBAS 6000 C501 MODULE. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 0.7 MG/DL AND IT REPEATED AS 123.3 MG/DL. THE 123.3 MG/DL VALUE WAS EXPECTED FOR THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18144318 ↗
  • MalfunctionOct 31, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

    THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUC HK GEN.3 (GLUCOSE) RESULT FROM THE COBAS 6000 C 501. THE INITIAL RESULT WAS 2 MG/DL AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 77 MG/DL AND WAS BELIEVED CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18039245 ↗
  • MalfunctionJul 20, 2023High Test Results; High Test Results

    THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 4 PATIENT SAMPLES TESTED WITH A PARTICULAR REAGENT LOT FOR GLUC3 GLUCOSE HK (GLUC3 ) ON A COBAS INTEGRA 400 PLUS. THE RESULTS WITH REAGENT LOT 625672 WERE HIGHER THAN THE REPEAT RESULTS WITH REAGENT LOT 698268. PATIENT 1 INITIAL RESULT WAS 132.5 MG/DL. THE REPEAT RESULT WAS 84.8 MG/DL. PATIENT 2 INITIAL RESULT WAS 133.3 MG/DL. THE REPEAT RESULT WAS 89.9MG/DL. PATIENT 3 INITIAL RESULT WAS 132.5 MG/DL. THE REPEAT RESULT WAS 84.8 MG/DL. PATIENT 4 INITIAL RESULT WAS 153.7 MG/DL. THE REPEAT RESULT WAS 111.2 MG/DL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17363135 ↗
  • MalfunctionJun 21, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SERUM SAMPLE TESTED WITH A MAGNESIUM ASSAY AND WITH A GLUCOSE ASSAY ON A COBAS 8000 COBAS C502 MODULE. MAGNESIUM: INITIAL RESULT: 0.95 MG/DL RERUN RESULT: 1.6 MG/DL. GLUCOSE: INITIAL RESULT : 37.1 MG/DL RERUN RESULT: 83.0 MG/DL. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17175367 ↗
  • MalfunctionMar 3, 2023Non Reproducible Results; Non Reproducible Results

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE GLUC3 (GLUCOSE HK GEN.3) ASSAY ON A COBAS 8000 COBAS C 502 MODULE, SERIAL NUMBER (B)(4). PATIENT SAMPLE 1, TESTED ON (B)(6) 2023: THE SAMPLE INITIALLY RESULTED IN A GLUC3 VALUE OF 0.01 MMOL/L AND REPEATED AS 5.54 MMOL/L PATIENT SAMPLE 2, TESTED ON (B)(6) 2023: THE SAMPLE INITIALLY RESULTED IN A GLUC3 VALUE OF 0.01 MMOL/L AND REPEATED AS 7.26 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16478340 ↗
  • MalfunctionJan 9, 2023Non Reproducible 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 6000 C (501) MODULE. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 3 MG/DL AND IT REPEATED AS 90 MG/DL. THE GLUCOSE REAGENT LOT NUMBER WAS 661054. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16120369 ↗
  • MalfunctionDec 28, 2022High Test Results; High Test Results

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR GLUC3 GLUCOSE HK (GLUC3) ON A COBAS 8000 C 502 MODULE. THE INITIAL RESULT WAS 172 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE IT WAS QUESTIONED BY THE PHYSICIAN. THE REPEAT RESULTS WERE 110 MG/DL, 110 MG/DL, AND 111 MG/DL. THESE RESULTS WERE BELIEVED TO BE CORRECT. THE GLUC3 REAGENT LOT NUMBER WAS 65281701 WITH AN EXPIRATION DATE OF 31-OCT-2023.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16060532 ↗

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