Elecsys total PSA 08791732190Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 07613336165980), received between Sep 15, 2021 and Sep 28, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (18 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917889 ↗
• MalfunctionSep 21, 2026Incorrect Measurement; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847596 ↗
• MalfunctionSep 17, 2026Low Test Results

  There was an allegation of questionable Elecsys total PSA results that were lower than their free PSA results for 11 patient samples on a cobas e 801 analytical unit.Below are examples of three patient sample results that were provided by the customer.Sample 1 had an initial result of 0.044 ng/mL and a repeat result of 1.440 ng/mL.The sample had a free PSA result of 0.431 ng/mL.Sample 2 had an initial result of 0.021 ng/mL and a repeat result of 1.480 ng/mL.The sample had a free PSA result of 0.386 ng/mL.Sample 3 had an initial result of 0.019 ng/mL and a repeat result of 1.150 ng/mL.The sample had a free PSA result of 0.205 ng/mL.The repeat total PSA results were deemed correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806939 ↗
• MalfunctionAug 11, 2026High Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50206288 ↗
• MalfunctionAug 10, 2026Low Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50198725 ↗
• MalfunctionJul 29, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50073147 ↗
• MalfunctionApr 16, 2026Incorrect Measurement; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TOTAL PSA AND ELECSYS FREE PSA ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FREE PSA ASSAY. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AS THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE SAMPLE RESULTED IN TOTAL PSA VALUES OF 0.10 NG/ML AND 0.0972 NG/ML. THE SAMPLE RESULTED IN FREE PSA VALUES OF 0.535 NG/ML AND 0.530 NG/ML. THE SAMPLE WAS TREATED WITH POLYETHYLENE GLYCOL (PEG) AND THE TESTS HAD A LOW RECOVERY RATE. DILUTION STUDIES SHOWED ABNORMAL RECOVERY WITH THE HIGHER DILUTION RATIOS. NO SPECIFIC DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24898939 ↗
• MalfunctionFeb 25, 2026Incorrect Measurement

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOTAL PSA ASSAY AND ELECSYS FREE PSA ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS FREE PSA ASSAY. THE INITIAL FREE PSA RESULT IS 0.243 NG/ML. THE INITIAL TOTAL PSA RESULT IS 0.0368 NG/ML. THE REPEAT RESULTS WERE CONSISTENT WITH THE INITIAL RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445677 ↗
• MalfunctionFeb 4, 2026Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOTAL PSA RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THIS MEDWATCH WILL APPLY TO THE ELECSYS TOTAL PSA (TPSA) ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT INDENTIFIER (B)(6) FOR THE INFORMATION RELATED TO THE ELECSYS FREE PSA (FPSA) ASSAY. THE INITIAL TPSA RESULT WAS 0.192 NG/ML, AND THE FPSA RESULT WAS 9.96 NG/ML. THE TPSA RESULT ON A SIEMENS INSTRUMENT WAS 6.71 NG/ML, AND THE FPSA RESULT WAS 0.04 NG/ML. THE TPSA RESULT ON (B)(6) 2026 ON THE E 801 WAS 0.174 NG/ML, AND THE FPSA RESULT WAS 10.1 NG/ML. THE TPSA RESULT ON (B)(6) 2026 ON THE E 602 WAS 0.160 NG/ML, AND THE FPSA RESULT WAS 10.58 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260460 ↗
• MalfunctionJan 20, 2026Incorrect Measurement; Output Problem

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FREE PSA (FREE PSA) AND ELECSYS TOTAL PSA (TOTAL PSA) ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER TOTAL PSA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FREE PSA RESULTS. THE INITIAL TOTAL PSA RESULT WAS 0.21 NG/ML. THE INITIAL FREE PSA RESULT WAS 10.50 NG/ML. THE REPEAT FREE PSA RESULT WAS 11.70 NG/ML. A NEW SAMPLE WAS OBTAINED, AND THE TOTAL PSA RESULT WAS 0.13 NG/ML. THE FREE PSA RESULT WAS 8.50 NG/ML. THE NEW SAMPLE WAS REPEATED BY THE SIEMENS METHOD, AND THE TOTAL PSA RESULT WAS 6.60 NG/ML, AND THE FREE PSA RESULT WAS 0.05 NG/ML. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ROCHE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121118 ↗
• MalfunctionDec 17, 2025Incorrect Measurement; Non Reproducible Results; Incorrect Measurement; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLES TESTED WITH ELECSYS TOTAL PSA ASSAY AND ELECSYS FREE PSA ASSAY ON A COBAS 8000 E 801 MODULE. THIS MEDWATCH WILL APPLY TO THE ELECSYS TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS FREE PSA ASSAY. THE FREE PSA (FPSA) VALUE WAS GREATER THAN THE TOTAL PSA (TPSA) VALUE. THE TPSA RESULTS WERE 0.0294 NG/ML (ACCOMPANIED BY A DATA FLAG), 0.0229 NG/ML (ACCOMPANIED BY A DATA FLAG), AND 0.563 NG/ML. THE FPSA RESULTS WERE 0.584 NG/ML, 0.853 NG/ML, AND 0.0413 NG/ML (ACCOMPANIED BY A DATA FLAG).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829748 ↗
• MalfunctionDec 11, 2025Incorrect Measurement; Unable to Obtain Readings; Incorrect Measurement; Unable to Obtain Readings

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TOTAL PSA AND ELECSYS FREE PSA ON TWO COBAS E 801 ANALYTICAL UNIT ANALYZERS. THE FREE PSA VALUE WAS LARGER THAN THE TOTAL PSA VALUE. THIS MEDWATCH WILL APPLY TO THE TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FREE PSA ASSAY. THE SAMPLE WAS TESTED THREE TIMES ON THE FIRST E801 ANALYZER, RESULTING IN THE FOLLOWING VALUES: TOTAL PSA = 0.172 NG/ML, 0.172 NG/ML, AND 0.174 NG/ML, FREE PSA = 0.203 NG/ML, 0.211 NG/ML, AND 0.195 NG/ML. THE SAMPLE WAS TESTED ON THE SECOND E801 ANALYZER, RESULTING IN THE FOLLOWING VALUES: TOTAL PSA = 0.185 NG/ML, FREE PSA = 0.191 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780728 ↗
• MalfunctionDec 5, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TOTAL PSA ASSAY ON A COBAS E 801 MODULE, WHICH DID NOT MATCH THE PATIENT'S CLINICAL CONDITION. INITIAL RESULT: 0.07 NG/ML. THE INITIAL RESULT ALSO DID NOT MATCH THE PATIENT'S PREVIOUS RESULTS OF <0.006 NG/ML, AND THE SAMPLE WAS THEN REPEATED ON (B)(6) 2025. REPEAT RESULT: <0.006 NG/ML. THE REPEAT RESULT WAS WITH THE EXPECTED VALUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729555 ↗
• MalfunctionNov 24, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOTAL PSA AND ELECSYS FREE PSA RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT THAT DID NOT AGREE WITH THE CLINICAL STATUS OF THE PATIENT. AN INTERFERENCE WAS SUSPECTED. THIS MEDWATCH IS FOR THE TOTAL PSA ASSAY. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE FREE PSA ASSAY. THE PATIENT HAD BEEN MONITORING HIS RESULTS SINCE 2015. THE RESULTS HAVE FLUCTUATED OVER THE YEARS, BUT THE TOTAL PSA RESULTS WERE AROUND 1.2-1.5 NG/ML, AND THE FREE PSA RESULTS WERE AROUND 0.18-0.2 NG/ML. TWO YEARS AGO, THE PATIENT HAD AN MRI, WHICH SHOWED NO CHANGES. WITHIN THE PAST MONTH, AN MRI REVEALED A LESION, AND THE BIOPSY CONFIRMED THE PRESENCE OF A MALIGNANT TUMOR. THE DOCTORS BELIEVE THE RESULTS SHOULD HAVE BEEN SIGNIFICANTLY HIGHER BASED ON THE PATIENT'S MRI AND BIOPSY. THE PATIENT HAD A TOTAL PSA PERFORMED AT ANOTHER LABORATORY, USING ABBOTT TECHNOLOGY, AND THE RESULT WAS 9 NG/ML. THE FOLLOWING DAY, THE TOTAL PSA RESULT USING THE COBAS E 801 ANALYTICAL UNIT WAS 1.79 NG/ML. A NEW SAMPLE WAS TAKEN FROM THE PATIENT, AND THE TOTAL PSA RESULT WAS 1.87 NG/ML, AND THE FREE PSA RESULT WAS 1.17 NG/ML. USING A COBAS PURE AT ANOTHER LABORATORY, THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630308 ↗
• MalfunctionNov 7, 2025Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLES TESTED WITH ELECSYS TOTAL PSA ASSAY AND ELECSYS FREE PSA ASSAY ON A COBAS 8000 E 801 MODULE. THIS MEDWATCH WILL APPLY TO THE TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FREE PSA ASSAY. TOTAL PSA: INITIAL RESULT: 0.0290 NG/ML. REPEAT RESULT: 0.0264 NG/ML. FREE PSA: INITIAL RESULT: 0.352 NG/ML. REPEAT RESULT: 0.351 NG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY, AS THE INITIAL RESULTS DID NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. THE CUSTOMER ALLEGED THAT THE FREE PSA RESULTS ARE HIGHER THAN THE TOTAL PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23500805 ↗
• MalfunctionOct 15, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR TWO SAMPLES FROM ONE PATIENT USING THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE TOTAL PSA ASSAY. REFER TO THE MEDWATCH WITH A1-PATIENT IDENTIFIER (B)(6) FOR THE FREE PSA ASSAY. FIRST SAMPLE: THE TOTAL PSA RESULT WAS 2.10 NG/ML. THE FREE PSA RESULT WAS 12.30 NG/ML. SECOND SAMPLE ((B)(6)2025): THE TOTAL PSA RESULT WAS 1.71 NG/ML. THE FREE PSA RESULT WAS 10.30 NG/ML. USING AN ALTERNATIVE METHODOLOGY (CHEMILUMINESCENCE): THE TOTAL PSA RESULT WAS 3.04 NG/ML. THE FREE PSA RESULT WAS 0.41 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289987 ↗
• MalfunctionAug 26, 2025Output Problem; Output Problem

  THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ELECSYS FREE PSA (FREE PSA) ON A COBAS E 801 ANALYTICAL UNIT. THE FREE PSA RESULTS WERE HIGHER THAN THE ELECSYS TOTAL PSA (TOTAL PSA) RESULTS. THIS MEDWATCH WILL COVER TOTAL PSA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FREE PSA RESULTS. EXAMPLES OF QUESTIONABLE RESULTS WERE PROVIDED FOR 3 PATIENT SAMPLES. PATIENT 1 FREE PSA RESULT WAS 0.0176 NG/ML. THE TOTAL PSA RESULT WAS 0.0073 NG/ML. PATIENT 2 FREE PSA RESULT WAS 0.0166 NG/ML. THE TOTAL PSA RESULT WAS 0.006 NG/ML WITH A DATA FLAG. ON (B)(6) 2025 PATIENT 3 FREE PSA RESULT WAS 0.0203 NG/ML. THE TOTAL PSA RESULT WAS 0.0110 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893287 ↗
• MalfunctionAug 19, 2025Incorrect, 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 ELECSYS TOTAL PSA RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS 6000 E601 MODULE. THE INITIAL TOTAL PSA RESULT WAS 4.57 NG/ML. THE REPEAT RESULT WAS 0.320 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842582 ↗
• MalfunctionAug 14, 2025Incorrect Measurement; Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOTAL PSA AND ELECSYS FREE PSA RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 402 ANALYTICAL UNIT. THE ELECSYS TOTAL PSA AND ELECSYS FREE PSA INITIAL RESULTS WERE BOTH MARKED BY "SAMP.C" ALARMS. THE SAMPLE WAS REPEATED. THE ELECSYS FREE PSA RESULT WAS 0.922 NG/ML. THE ELECSYS TOTAL PSA RESULT WAS 0.497 NG/ML. THE TECHNICIAN OBSERVED RED DOTS IN THE SERUM SAMPLE. ON (B)(6) 2025, AN ALIQUOT OF THE SAMPLE WAS RECENTRIFUGED AND TESTED. THE ELECSYS FREE PSA RESULT WAS 0.187 NG/ML. THE ELECSYS TOTAL PSA RESULT WAS 0.482 NG/ML. THIS MEDWATCH WILL APPLY TO THE ELECSYS TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS FREE PSA ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805863 ↗
• MalfunctionAug 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE RESULT NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR ELECSYS TOTAL PSA (TOTAL PSA) ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2024, THE PATIENT HAD A TOTAL PSA RESULT FROM A SIEMENS SYSTEM OF 10.31 NG/ML. ON (B)(6) 2025, THE PATIENT HAD A RESULT ON THE E801 ANALYZER OF 4.21 NG/ML. THE SAMPLE WAS REPEATED, AND THE RESULT WAS 4.09 NG/ML. ON (B)(6) 2025, THE RESULT FROM A NEW SAMPLE ON THE E801 ANALYZER WAS 1.79 NG/ML. THE PHYSICIAN QUESTIONED HOW THE RESULT COULD CHANGE FROM 4.09 NG/ML IN (B)(6) 2025 TO 1.79 NG/ML IN (B)(6) 2025 WHEN THE PATIENT IS NOT BEING TREATED FOR PROSTATE CANCER. THE PATIENT ONLY TAKES ROSUVASTATIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22729596 ↗
• MalfunctionJul 31, 2025Incorrect, 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 UNDETECTABLE LOW ELECSYS TOTAL PSA RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE NUMBER OF PATIENTS WAS NOT SPECIFIED; RESULTS WERE PROVIDED FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT WAS 0.15 UG/L, AND THE REPEAT RESULT WAS 0.01 UG/L, ACCOMPANIED BY A DATA FLAG. PATIENT 2'S INITIAL RESULT ON (B)(6) 2025 WAS 1.38 UG/L, WITH 2 REPEAT RESULTS OF 0.01 UG/L, ACCOMPANIED BY A DATA FLAG. ANOTHER REPEAT RESULT WAS 0.006 UG/L, ACCOMPANIED BY A DATA FLAG. THIS REPEAT RESULT IS CONSISTENT WITH THE PATIENT'S HISTORY. IT WAS PROVIDED THAT PATIENT 1 IS MONITORED AS THEY HAVE UNDERGONE SURGERY AND OCCASIONALLY SEE HIGHER RESULTS, BUT ON REPEAT THE RESULT IS LOWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675059 ↗
• MalfunctionJul 28, 2025Output Problem; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TOTAL PSA (TPSA) AND ELECSYS FREE PSA (FPSA) ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE ELECSYS TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS FREE PSA ASSAY. THE FREE PSA (FPSA) VALUE WAS GREATER THAN THE TOTAL PSA (TPSA) VALUE. THE TPSA RESULTS WERE 1.22 AND 1.33 NG/ML. THE FPSA RESULTS WERE 1.98 AND 1.87 NG/ML. THE SAME SAMPLE WAS REPEATED AFTER RECALIBRATION AND ON ANOTHER MODULE. THE RESULTS REMAINED THE SAME; HOWEVER, THE ACTUAL VALUES WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628853 ↗
• MalfunctionJun 16, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOTAL PSA RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT FOR A PATIENT WHO HAD RECEIVED RADIOTHERAPY OR A PROSTATECTOMY. THE INITIAL RESULT WAS 0.00600 NG/ML WITH A DATA FLAG. THE AUTOMATIC REPEAT RESULT WAS 0.201 NG/ML. THE RESULT FROM ANOTHER COBAS PRO ANALYZER WAS 0.00600 NG/ML WITH A DATA FLAG. THE RESULT OF 0.00600 NG/ML WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210562 ↗
• MalfunctionMay 20, 2025Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOTAL PSA (TOTAL PSA) ASSAY AND ELECSYS FREE PSA (FREE PSA) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PURE E 402 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS TOTAL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS FREE PSA (TOTAL PSA) ASSAY. TOTAL PSA THE INITIAL RESULT FROM THE ANALYZER WAS 0.172 NG/ML. THE REPEAT RESULT FROM THE COBAS E 801 ANALYZER WAS 0.186 NG/ML. THE REPEAT RESULT FROM A REFERRAL LABORATORY USING THE CHEMILUMINESCENT IMMUNOASSAY (CLIA) LABORATORY METHOD WAS 0.36 NG/ML. FREE PSA THE INITIAL RESULT FROM THE ANALYZER WAS 0.443 NG/ML. THE REPEAT RESULT FROM THE COBAS E 801 ANALYZER WAS 0.447 NG/ML. THE REPEAT RESULT FROM A REFERRAL LABORATORY USING THE CLIA LABORATORY METHOD WAS 0.10 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22051703 ↗
• MalfunctionMay 15, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOTAL PSA (TOTAL PSA) ASSAY AND FREE PSA ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS TOTAL PSA (TOTAL PSA) ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT-0076154 FOR THE FREE PSA ASSAY. TOTAL PSA: THE INITIAL RESULT FROM THE ANALYZER WAS 0.282 NG/ML. THE REPEAT RESULT FROM A COMPETITOR ANALYZER WAS 2.183 NG/ML. THE PATIENT SAMPLE WAS DILUTED WITH INCREASING AMOUNTS OF NEGATIVE SERUM (THE VALUE WAS LOWER THAN THE LEVEL OF DETECTION LOD): THE REPEAT RESULT AT 1:2 DILUTION WAS 0.143 NG/ML. THE REPEAT RESULT AT 1:4 DILUTION WAS 0.0787 NG/ML. THE REPEAT RESULT AT 1:8 DILUTION WAS 0.0418 NG/ML. FREE PSA: THE INITIAL RESULT FROM THE ANALYZER WAS 1.21NG/ML. THE REPEAT RESULT FROM A COMPETITOR ANALYZER WAS 1.403 NG/ML. THE PATIENT SAMPLE WAS DILUTED WITH INCREASING AMOUNTS OF NEGATIVE SERUM (THE VALUE WAS LOWER THAN THE LEVEL OF DETECTION LOD): THE REPEAT RESULT AT 1:2 DILUTION WAS 0.588 NG/ML. THE REPEAT RESULT AT 1:4 DILUTION WAS 0.311 NG/ML. THE REPEAT RESULT AT 1:8 DILUTION WAS 0.156 NG/ML. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025954 ↗