Elecsys free PSA 08828610190Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07613336166628), received between Oct 20, 2021 and Sep 21, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (17 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Incorrect Measurement; Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847598 ↗
• MalfunctionFeb 4, 2026Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FREE PSA RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THIS MEDWATCH WILL APPLY TO THE ELECSYS FREE PSA (FPSA) ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT INDENTIFIER (B)(6) FOR THE INFORMATION RELATED TO THE ELECSYS TOTAL PSA (TPSA) 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 24260447 ↗
• 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 FREE PSA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TOTAL 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 24121123 ↗
• 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 FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) FOR INFORMATION RELATED TO THE ELECSYS TOTAL 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 23830048 ↗
• 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 FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TOTAL 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 23780709 ↗
• 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 FREE PSA ASSAY. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE TOTAL 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 23630312 ↗
• 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 FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TOTAL 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 23500804 ↗
• 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 FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) FOR INFORMATION RELATED TO THE ELECSYS TOTAL PSA ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805861 ↗
• MalfunctionJul 28, 2025Output Problem; Output Problem

  THERE WAS AN ALLEGATION OF 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 ELECSYS FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS TOTAL 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 22628882 ↗
• MalfunctionJun 13, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS FREE PSA RESULT FROM THE COBAS E 402 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE ELECSYS FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT INDENTIFIER (B)(6) FOR THE INFORMATION RELATED TO THE ELECSYS TOTAL PSA ASSAY. THE INITIAL FREE PSA RESULT WAS 0.275 NG/ML, AND A TOTAL PSA FROM A COBAS E 411 WITH A RESULT OF 0.063 NG/ML. THE SAMPLE WAS SENT TO ANOTHER LAB AND RAN ON ANOTHER COBAS E 411 ANALYZER WITH THE SAME RESULTS OF FREE PSA GREATER THAN TOTAL PSA. THE CUSTOMER THEN RAN THE SAMPLE ON AN ABBOTT PLATFORM, AND THE FREE PSA RESULT WAS 0.04 NG/ML, AND THE TOTAL PSA RESULT WAS 0.08 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202252 ↗
• 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 FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS TOTAL 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 22051696 ↗
• 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 FREEL PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS TOTAL PSA (TOTAL 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, AS THE RESULT 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, AS THE RESULT 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 OUTSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026606 ↗
• MalfunctionFeb 11, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ELECSYS FREE PSA (FREE PSA) ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 1.01 NG/ML. THE REPEAT RESULT WAS 0.364 NG/ML. PATIENT 2 INITIAL RESULT WAS 1.88 NG/ML. THE REPEAT RESULT WAS 0.451 NG/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354459 ↗
• MalfunctionJan 14, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE HIGH ELECSYS FREE PSA RESULT FROM THE COBAS E 801 MODULE. THE INITIAL RESULT WAS 11.4 NG/ML. THE REPEAT RESULT WAS 0.151 NG/ML. THE INCORRECT RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY TO THE CLINIC OR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149193 ↗
• MalfunctionMay 16, 2024High Test Results; Mechanical Jam; Non Reproducible Results; High Test Results; Mechanical Jam; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS FREE PSA IMMUNOASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS REPORTED TO THE CLINIC. THE CLINICAL COMPLAINT PROMPTED THE RERUN OF THE PATIENT SAMPLE. THE INITIAL FREE PSA RESULT WAS 4.57 NG/ML. THE FIRST REPEAT RESULT WAS 0.530 NG/ML. THE SECOND REPEAT RESULT WAS 0.518 NG/ML. THE THIRD REPEAT RESULT AFTER HIGH-SPEED CENTRIFUGATION WAS 0.521 NG/ML. THE TOTAL PSA RESULT WAS 2.9 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19335226 ↗
• MalfunctionApr 10, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FREE PSA IMMUNOASSAY RESULTS COMPARED TO TOTAL PSA RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A SIEMENS ANALYZER. THIS MEDWATCH WILL COVER FREE PSA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT (B)(6) FOR INFORMATION ON THE TOTAL PSA RESULTS. ON (B)(6) 2024, THE PATIENT HAD A SAMPLE TESTED ON MODULE 3 FREE PSA RESULT OF 1.23 NG/ML AND A TOTAL PSA RESULT OF 0.101 NG/ML. ON (B)(6) 2024, THE SAMPLE WAS REPEATED ON A SIEMENS ANALYZER AND THE FREE PSA RESULT WAS 0.03 NG/ML AND THE TOTAL PSA RESULT WAS 1.04 NG/ML. ON (B)(6) 2024, THE PATIENT HAD A SAMPLE TESTED ON MODULE 4 AND THE FREE PSA RESULT WAS 1.20 NG/ML AND A TOTAL PSA RESULT OF 0.103 NG/ML. ON (B)(6) 2024, THE SAMPLE WAS REPEATED ON A SIEMENS ANALYZER AND THE FREE PSA RESULT WAS 0.03 NG/ML AND THE TOTAL PSA RESULT WAS 1.00 NG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080577 ↗
• MalfunctionNov 21, 2023Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FREE PSA AND ELECSYS TOTAL PSA ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TOTAL PSA ASSAY. THE SAMPLE RESULTED IN FREE PSA VALUES OF 0.205 NG/ML AND 0.206 NG/ML WHEN TESTED ON THE E 801 ANALYZER. THE SAMPLE WAS TESTED ON A SECOND ANALYZER, RESULTING IN A FREE PSA VALUE OF 0.0747 NG/ML. THE 0.0747 NG/ML VALUE AGREED WITH THE PATIENT'S PREVIOUS RESULTS. THE SAMPLE RESULTED IN A TOTAL PSA VALUE OF 0.195 NG/ML WHEN TESTED ON THE E801 ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182711 ↗
• MalfunctionNov 16, 2023Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FREE PSA (FREE PSA) ON TWO COBAS E 801 ANALYTICAL UNITS. THE FREE PSA RESULTS WERE GREATER THAN THE TOTAL PSA RESULTS. THIS MEDWATCH WILL COVER FREE PSA. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TOTAL PSA RESULTS. ON E801 ANALYZER 1: THE FREE PSA RESULT WAS 1.79 NG/ML. THE TOTAL PSA RESULT WAS 0.0501 NG/ML. ON E801 ANALYZER 2: THE FREE PSA RESULT WAS 1.68 NG/ML. THE TOTAL PSA RESULT WAS 0.0552 NG/ML. THE SAMPLE WAS MANUALLY DILUTED X3: THE FREE PSA RESULT WAS 1.632 NG/ML. THE TOTAL PSA RESULT WAS 0.064 NG/ML. ON (B)(6) 2023 THE SAMPLE WAS TESTED BY COMPETITOR METHOD 1: THE FREE PSA RESULT WAS 1.51 NG/ML. THE TOTAL PSA RESULT WAS 1.66 NG/ML. THE SAMPLE WAS TESTED BY COMPETITOR METHOD 2: THE FREE PSA RESULT WAS 0.022 NG/ML. THE TOTAL PSA RESULT WAS 0.190 NG/ML. THE QUESTIONABLE RESULTS DID NOT MATCH THE PATIENT¿S CLINICAL DIAGNOSIS AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18150401 ↗
• MalfunctionNov 15, 2023Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER QUESTIONED A RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS FREE PSA (FREE PSA) ON A COBAS E 801 ANALYTICAL UNIT. THE FREE PSA RESULT WAS 0.49 UG/L. THE TOTAL PSA RESULT FROM THE E801 ANALYZER WAS 0.07 UG/L. ON (B)(6)2023 THE TOTAL PSA RESULT FROM A COMPETITOR METHOD WAS <0.10 UG/L. THE CUSTOMER SUSPECTS AN INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138874 ↗
• MalfunctionJul 12, 2023Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM TWO PATIENTS TESTED WITH THE ELECSYS FREE PSA AND THE ELECSYS TOTAL PSA ASSAY ON A COBAS E 801 MODULE. THE FREE PSA VALUES WERE GREATER THAN THE TOTAL PSA VALUES. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TOTAL PSA ASSAY. PATIENT 1: ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN A FREE PSA VALUE OF 0.0138 NG/ML AND REPEATED AS 0.0138 NG/ML. ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN A TOTAL PSA VALUE OF < 0.006 NG/ML, ACCOMPANIED BY A DATA FLAG. PATIENT 2: ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN A FREE PSA VALUE OF 0.0114 NG/ML. ON (B)(6) 2023, THE SAMPLE WAS REPEATED, RESULTING IN A FREE PSA VALUE OF 0.0105 NG/ML. ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN A TOTAL PSA VALUE OF < 0.006 NG/ML, ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2023, THE SAMPLE INITIALLY RESULTED IN A TOTAL PSA VALUE OF < 0.006 NG/ML, ACCOMPANIED BY A DATA FLAG. THE SERIAL NUMBER OF THE COBAS E 801 MODULE IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309611 ↗
• MalfunctionMar 15, 2023Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT TESTED WITH THE ELECSYS FREE PSA AND THE ELECSYS TOTAL PSA ASSAY ON A COBAS E 801 ANALYTICAL UNIT. THE FREE PSA VALUES WERE GREATER THAN THE TOTAL PSA VALUES. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FREE PSA ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TOTAL PSA ASSAY. A FIRST SAMPLE OF THE PATIENT WAS TESTED ON (B)(6) 2023: THE FIRST SAMPLE INITIALLY RESULTED IN A FREE PSA VALUE OF 2.88 NG/ML. THE FIRST SAMPLE INITIALLY RESULTED IN A TOTAL PSA VALUE OF 0.180 NG/ML. A SECOND SAMPLE OF THE PATIENT WAS TESTED ON AN UNKNOWN DATE: THE SECOND SAMPLE INITIALLY RESULTED IN A FREE PSA VALUE OF 2.79 NG/ML AND REPEATED IN A DIFFERENT LABORATORY ON A COBAS PURE ANALYZER AS 2.74 NG/ML. THE SECOND SAMPLE INITIALLY RESULTED IN A TOTAL PSA VALUE OF 0.174 NG/ML AND REPEATED IN A DIFFERENT LABORATORY ON A COBAS PURE ANALYZER AS 0.19 NG/ML. THE PATIENT WENT TO ANOTHER LABORATORY AND RECEIVED A FREE PSA VALUE OF 0.068 NG/ML AND A TOTAL PSA VALUE OF 0.415 NG/ML. THE METHOD USED AND THE DATE OF M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549458 ↗
• MalfunctionNov 9, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FREE PSA IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL FREE PSA RESULT WAS 6.58 NG/ML. THE REPEAT RESULT WAS 3.19 NG/ML. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS DEEMED CORRECT. THE REAGENT LOT IS 61763201. THE EXPIRATION DATE IS 30-JUN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762663 ↗
• MalfunctionSep 28, 2022Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TOTAL PSA IMMUNOASSAY AND ELECSYS FREE PSA IMMUNOASSAY RESULTS FROM 1 PATIENT ON A ROCHE IMMUNOASSAY ANALYZER. THE INITIAL TOTAL PSA RESULT WAS 9.78 NG/ML AND THE FIRST REPEAT RESULT WAS 9.73 NG/ML. THE INITIAL FREE PSA RESULT WAS 12.9 NG/ML AND THE FIRST REPEAT RESULT WAS 13.5 NG/ML. A DILUTION WAS PERFORMED AND THE SECOND REPEAT TOTAL PSA RESULT WAS 9.56 NG/ML AND THE SECOND REPEAT FREE PSA RESULT WAS 13.6 NG/ML. IT IS UNCLEAR IF THESE RESULTS WERE FROM A SEPARATE SAMPLE. IT IS UNKNOWN IF ANY RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER MODEL AND SERIAL NUMBER WERE REQUESTED BUT NOT PROVIDED. THIS MEDWATCH WILL COVER FREE PSA. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6)FOR INFORMATION ON THE TOTAL PSA RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496262 ↗
• MalfunctionOct 21, 2021Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER QUESTIONED RESULTS FOR 2 PATIENT SAMPLES TESTED FOR FREE PSA ELECSYS E2G 300 V2 (FREE PSA) AND TOTAL PSA ELECSYS E2G 300 V2 (TOTAL PSA) ON A COBAS E801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER FREE PSA. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TOTAL PSA RESULTS. PATIENT 1 TOTAL PSA RESULT FROM THE E801 ANALYZER WAS 0.0423 NG/ML AND THE FREE PSA RESULT WAS 0.0724 NG/ML. THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON THE E801 ANALYZER WITH A TOTAL PSA RESULT OF 0.043 NG/ML AND A FREE PSA RESULT OF 0.0734 NG/ML. THE SAMPLE WAS REPEATED AGAIN ON THE E801 ANALYZER WITH A TOTAL PSA RESULT OF 0.0422 NG/ML AND A FREE PSA RESULT OF 0.0751 NG/ML. ON (B)(6) 2021 THE SAMPLE FOR PATIENT 1 WAS TESTED BY THE MINDRAY METHOD WITH A TOTAL PSA RESULT OF 0.025 NG/ML AND A FREE PSA RESULT OF 0.038 NG/ML. ON (B)(6) 2021 THE SAMPLE FOR PATIENT 1 WAS TESTED BY THE ABBOTT METHOD WITH A TOTAL PSA RESULT OF 0.04 NG/ML AND A FREE PSA RESULT OF 0.026 NG/ML. ON (B)(6) 2021 PATIENT 2 INITIAL TOTAL PSA RESULT WAS 0.17 NG/ML AND THE FREE PSA RESULT WAS 0.901 NG/ML. THE SAMPLE FOR PATIENT 2 WAS TESTED BY THE MINDRAY METHOD AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674199 ↗
• MalfunctionOct 20, 2021Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER QUESTIONED RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TOTAL PSA ELECSYS E2G 300 V2 (TOTAL PSA) AND FREE PSA ELECSYS E2G 300 V2 (FREE PSA) ON A COBAS E801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER FREE PSA. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TOTAL PSA RESULTS. THE INITIAL FREE PSA RESULT WAS 0.0259 NG/ML AND THE INITIAL TOTAL PSA RESULT WAS 0.0067 NG/ML. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE CLINICIANS QUESTIONED THE RESULTS AS A FREE PSA RESULT GREATER THAN A TOTAL PSA WAS BELIEVED TO BE "IMPOSSIBLE." ON (B)(6) 2021 THE SAMPLE WAS REPEATED WITH A FREE PSA RESULT OF 0.0268 NG/ML AND A TOTAL PSA RESULT OF 0.00908 NG/ML. QC WAS ACCEPTABLE, HOWEVER, CALIBRATION HAD "EXPIRED." THE CUSTOMER RECALIBRATED BOTH ASSAYS AND RAN ACCEPTABLE QC. THE SAMPLE WAS REPEATED AGAIN AND THE FREE PSA RESULT WAS 0.0100 NG/ML WITH A DATA FLAG AND THE TOTAL PSA RESULT WAS 0.00600 WITH A DATA FLAG NG/ML. THE E801 ANALYZER SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666935 ↗