cobas c 503 analytical unit 08463662001Recalls & reported problems

Summary

The FDA's MAUDE database contains 333 adverse event reports that list this exact device (DI 07613336158784), received between Apr 23, 2020 and Feb 29, 2024 — classified as 333 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (133 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 333 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 29, 2024Incorrect, 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

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 AND CALCIUM GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL GLUCOSE RESULT WAS 26 MG/DL. THE REPEATED GLUCOSE RESULT WAS 122 MG/DL. THE INITIAL CA RESULT WAS 5.59 MG/DL. THE REPEATED CA RESULT WAS 8.51 MG/DL. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE USER QUESTIONED THE INITIAL GLUCOSE RESULT AND REPEATED THE SAMPLE ON ANOTHER ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806083 ↗
• MalfunctionFeb 23, 2024High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE CREAJ2 (CREATININE) RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE ANALYZER WAS 2.83 MG/DL. THE REPEAT RESULT FROM ANOTHER C 503 ANALYZER WAS 0.90 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT AND REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772967 ↗
• MalfunctionFeb 19, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY HAD TO CORRECT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR MULTIPLE ANALYTES ON THE COBAS C 503 ANALYTICAL UNIT ON (B)(6)2023. THE CUSTOMER NOTED THEY RECEIVED ASPIRATION ERRORS ON THE ANALYZER ON (B)(6) 2023, SO THEY CLEANED THE PROBE AND CONTROLS PASSED ON (B)(6) 2023. THE CUSTOMER THEN NOTICED SEVERAL PATIENT SAMPLES HAD LOW RESULTS AND THESE DID NOT AGREE WITH THE CLINICAL PICTURE OF THE PATIENTS. THE CUSTOMER RAN CONTROLS AND THESE FAILED FOR AT LEAST 4 DIFFERENT ANALYTES. THE CUSTOMER REPEATED 84 PATIENT SAMPLES. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE WITH DISCREPANT RESULTS FOR GLUCOSE HK GEN.3. THIS SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 100 MG/DL. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING IN A GLUCOSE VALUE OF 70 MG/DL. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18730233 ↗
• MalfunctionFeb 16, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 MODULE. THE INITIAL RESULT WAS 8.19 MG/DL. THE REPEATED RESULT WAS 104 MG/DL. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED DUE TO THE CUSTOMER QUESTIONING THE INITIALLY LOW RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721851 ↗
• MalfunctionFeb 16, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 MODULE. THE INITIAL RESULT WAS 58.6 MG/DL. THE CUSTOMER'S MIDDLEWARE ROUNDED THE RESULT TO 59 MG/DL. THE INITIAL RESULT WAS QUESTIONED BY THE PHYSICIAN AND THE SAMPLE WAS REPEATED. THE REPEATED RESULTS WERE 97.6 MG/DL AND 97.6 MG/DL. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT. THE SECOND REPEATED RESULT WAS OBTAINED ON ANOTHER ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720116 ↗
• MalfunctionFeb 14, 2024Unable to Obtain Readings; Non Reproducible Results; Unable to Obtain Readings; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH GLUCOSE HK GEN.3 (GLUC3) ASSAY ON A COBAS PRO C503 ANALYZER WHEN COMPARED TO A DIFFERENT COBAS PRO C503 ANALYZER. INITIAL RESULT: 8 MG/DL. THE CUSTOMER NOTICED THAT THE RESULT WAS LOW AND RE-TESTED THE SAMPLE. REPEAT RESULT: 30 MG/DL (TESTED ON ANOTHER C503). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705441 ↗
• MalfunctionFeb 14, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE CREATININE, PHOSPHORUS, AND CALCIUM RESULTS FROM FOUR PATIENT SAMPLES TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. IT IS UNKNOWN IF THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. SAMPLE ID (B)(6) THE INITIAL RESULTS WERE OBTAINED ON 16-JAN-2024. THE REPEAT RESULTS WERE OBTAINED ON (B)(6) 2024. THE INITIAL CREATININE RESULT FROM THE ANALYZER WAS 65.7 UMOL/L. THE REPEAT RESULT FROM THEIR OTHER LINE WAS 85.7 UMOL/L. THE INITIAL PHOSPHORUS RESULT FROM THE ANALYZER WAS 0.710 MMOL/L. THE REPEAT RESULT FROM THEIR OTHER LINE WAS 1.10 MMOL/L. THE INITIAL CALCIUM RESULT FROM THE ANALYZER WAS 1.72 MMOL/L. THE REPEAT RESULT FROM THEIR OTHER LINE WAS 2.38 MMOL/L. SAMPLE ID (B)(6) ON (B)(6) 2024: THE INITIAL CALCIUM RESULT FROM THE ANALYZER WAS 1.67 MMOL/L. THE REPEAT RESULT FROM THEIR OTHER LINE WAS 2.35 MMOL/L. SAMPLE ID (B)(6) THE REPEAT RESULTS FROM THEIR OTHER LINE WERE OBTAINED ON (B)(6) 2024. THE INITIAL PHOSPHORUS RESULT FROM THE ANALYZER WAS 0.493 MMOL/L. THE FIRST REPEAT RESULT FROM THEIR OTHER LINE WAS 0.933 MMOL/L. THE SECOND REPEAT RESULT FROM THEIR OTHER LINE WAS 0.936 MMOL/L. THE INITIAL CALCIUM RESULT FROM THE ANALYZER WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704768 ↗
• MalfunctionFeb 14, 2024Low Test Results; Output Problem; Low Test Results; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL CRP RESULT WAS 1.99 MG/L THE REPEAT RESULTS WERE 81.4 MG/L AND 82.3 MG/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704435 ↗
• MalfunctionFeb 12, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE DIAGNOSTICS MAGNESIUM REAGENT RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 MODULE. THE INITIAL RESULT WAS 2.7 MG/DL. THE SAMPLE WAS AUTOMATICALLY REPEATED AND THE RESULT WAS 3.8 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE RESULT WAS 2.5 MG/DL. THE SAMPLE WAS REPEATED DUE TO THE CUSTOMER AUTOMATICALLY REPEATING ALL MAGNESIUM TESTS. IT IS UNKNOWN WHICH RESULT IS CORRECT. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687162 ↗
• MalfunctionFeb 7, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CA2 (CALCIUM), PHOS2 (PHOSPHORUS), AND COBAS INTEGRA GLUCOSE HK GEN. 3 ON A COBAS PRO C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED DUE TO LOW TEST RESULTS. THE REPEAT RESULTS WERE DEEMED CORRECT. THE SAMPLE RESULTED IN THE FOLLOWING INITIAL VALUES: CALCIUM = 5.17 MG/DL PHOSPHORUS = 0.746 MG/DL GLUCOSE = 112 MG/DL. THE SAMPLE REPEATED WITH THE FOLLOWING VALUES: CALCIUM = 8.11 MG/DL PHOSPHORUS = 1.05 MG/DL GLUCOSE = 147 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18661712 ↗
• MalfunctionFeb 6, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE MAGNESIUM (MG2) RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS C 503 MODULE. THE INITIAL MAGNESIUM RESULT WAS 1.44 MMOL/L AND THE REPEAT RESULTS WERE 0.796 MMOL/L AND 0.784 MMOL/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650181 ↗
• MalfunctionFeb 6, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LITHIUM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 MODULE. THE INITIAL RESULT WAS 1.27 MMOL/L. THE REPEATED RESULT WAS 0.326 MMOL/L. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE MEDICAL PERSONNEL COMPLAINED ABOUT THE HIGH RESULT WHICH CAUSED THE CUSTOMER TO REPEAT THE TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649371 ↗
• MalfunctionFeb 5, 2024High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR TRIGLYCERIDES (TRIGL) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 5.27 G/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 1.00 G/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641006 ↗
• MalfunctionFeb 2, 2024High Test Results; Output Problem; High Test Results; Output Problem

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREATINE KINASE ON A COBAS PRO C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A CK VALUE OF > 2195 U/L WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY REPEATED WITH DECREASED SAMPLE VOLUME, RESULTING IN A VALUE OF 209 U/L. SINCE THE REPEAT VALUE OBTAINED WITH DECREASED SAMPLE VOLUME DID NOT AGREE WITH THE INITIAL VALUE, THE SAMPLE WAS REPEATED A SECOND TIME, RESULTING IN A VALUE THAT WAS BELOW THE ASSAY MEASURING RANGE AND FLAGGED. THE SPECIFIC VALUE WAS NOT PROVIDED. THE SAMPLE WAS TESTED ON A SECOND ANALYZER, RESULTING IN A CK VALUE OF 2218 U/L. THE SAMPLE WAS REPEATED ON THE COMPLAINED ANALYZER ON (B)(6)2024, RESULTING IN A CK VALUE OF > 2187 U/L WITH A DATA FLAG. THE SAMPLE WAS THEN AUTOMATICALLY REPEATED WITH DECREASED SAMPLE VOLUME, RESULTING IN A CK VALUE OF 2277 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635617 ↗
• MalfunctionFeb 1, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LOW CALCIUM GEN (CA2) RESULTS FROM THE COBAS PRO C 503 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 5.63 MG/DL AND THE REPEAT RESULT ON THE SAME ANALYZER WAS 7.34 MG/DL. THE REPEAT RESULT ON THE OTHER COBAS PRO C 503 ANALYTICAL UNIT WAS 7.34 MG/DL. PATIENT 2 INITIAL RESULT WAS 5.8 MG/DL AND THE REPEAT RESULT ON THE SAME ANALYZER WAS 7.8 MG/DL. THE REPEAT RESULT ON THE OTHER COBAS PRO C 503 ANALYTICAL UNIT WAS 8.1 MG/DL. THE RESULT OF 7.8 MG/DL. WAS BELIEVED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624390 ↗
• MalfunctionFeb 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH CALCIUM GEN 2 (CA2) RESULT FROM THE COBAS PRO C 503 ANALYTICAL UNIT. THE CUSTOMER COULD NOT PROVIDE SPECIFIC PATIENT DATA BUT STATED THE RESULTS ARE 1.0 - 1.5 MG/DL DIFFERENT BETWEEN THE TWO COBAS PRO C 503 ANALYTICAL UNIT AT THE CUSTOMER SITE. THE LOW REPEAT RESULTS FROM COBAS PRO C 503 ANALYTICAL UNIT 22K8-01 WERE BELIEVED CORRECT AND CORRECTED REPORTS WERE ISSUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624385 ↗
• MalfunctionJan 31, 2024High Test Results; High Test 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 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 48 MG/DL. THE REPEAT RESULT WAS 129 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18618968 ↗
• MalfunctionJan 30, 2024Incorrect, 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 TWO PATIENT SAMPLES TESTED WITH LACT2 (LACTATE) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE CUSTOMER RECEIVED A PHOTOMETER ERROR ON THE ANALYZER, SO THEY REPEATED THE SAMPLES ON A SECOND ANALYZER. THE REPEAT VALUES WERE DEEMED CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN A LACTATE VALUE OF 0.3 MMOL/L AND IT REPEATED AS 1.2 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A LACTATE VALUE OF 1.1 MMOL/L AND IT REPEATED AS 3.5 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608825 ↗
• MalfunctionJan 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE MAGNESIUM RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES ON A COBAS PRO C 503 MODULE. AN EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 3.5 MG/DL. THE SAMPLE WAS AUTOMATICALLY REPEATED AND THE RESULT WAS 5.8 MG/DL. THE SAMPLE WAS TESTED ON ANOTHER ANALYZER AND THE RESULTS WERE 3.56 MG/DL AND 3.49 MG/DL. IT IS UNKNOWN WHICH RESULT IS CORRECT. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591694 ↗
• MalfunctionJan 26, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT HEMOGLOBIN A1CDX GEN. 3 (A1CX3) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 8.56%. THE REPEAT RESULT WAS 6.99%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588180 ↗
• MalfunctionJan 25, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 10 PATIENT SAMPLES TESTED FOR MULTIPLE PARAMETERS ON A COBAS C 503 ANALYTICAL UNIT. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE TESTED FOR GLUCOSE HK GEN.3. THE INITIAL RESULT FROM THE(B)(6) ANALYZER WAS 35 MG/DL. AS THIS RESULT DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL HISTORY, A CAPILLARY TEST WAS PERFORMED AND THE GLUCOSE RESULT WAS 80 MG/DL. THE ORIGINAL SAMPLE WAS REPEATED ON THE (B)(6) ANALYZER WITH A RESULT OF 78 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18582523 ↗
• MalfunctionJan 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE ASSAYS AND MULTIPLE PATIENT SAMPLES TESTED ON A COBAS C 503 ANALYTICAL UNIT. DISCREPANT RESULTS WERE PROVIDED FOR 2 PATIENT SAMPLES TESTED FOR ALB BCG GEN.2 (ALB2), CRPHS, AND MAGNESIUM REAGENT (MG2). PATIENT 1 INITIAL ALB2 RESULT WAS 5.02 G/DL. THE REPEAT RESULT WAS 3.66 G/DL. PATIENT 2 INITIAL CRPHS RESULT WAS 5.95 MG/L. THE REPEAT RESULT WAS 37.8 MG/L. THE INITIAL MG2 RESULT WAS 3.39 MG/DL. THE REPEAT RESULT WAS 2.06 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON A DIFFERENT C503 ANALYZER. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18468319 ↗
• MalfunctionJan 8, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE GLUC3 GLUCOSE HK GEN.3 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT WAS ACCOMPANIED BY A DATA FLAG IN THEIR LABORATORY INFORMATION SYSTEM (LIS) AND WAS DEEMED A CRITICALLY LOW RESULT THAT DID NOT MATCH THE CLINICAL PICTURE OF THE PATIENT, PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE INITIAL RESULT WAS 3.92 MG/DL. THE REPEAT RESULT WAS 174 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18463068 ↗
• MalfunctionJan 5, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 MODULE. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AS THE RESULTS DID NOT MATCH THE PATIENTS' CLINICAL CONDITION ALERTING THE USER TO AN ISSUE WITH THE RESULTS. THE INITIAL RESULT WAS 20.3 MG/DL. THE REPEATED RESULT WAS 106 MG/DL. THE REPEATED RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455793 ↗
• MalfunctionJan 4, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL CA2 RESULT WAS 5.1 MG/DL. THE CUSTOMER QUESTIONED THE LOW RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT AND REPEATED THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER COBAS PRO ANALYZER AND THE RESULT WAS 8.6 MG/DL. THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF HE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445085 ↗