Elecsys HCG+beta 07251025190Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 04015630939732), received between Aug 13, 2018 and Apr 11, 2026 — classified as 58 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (42 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Incorrect Measurement; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 SAMPLES FROM THE SAME PATIENT'S BLOOD DRAW TESTED WITH ELECSYS HCG+SS ASSAY ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1: THE INITIAL RESULT WAS <0.200 MIU/ML (TESTED IN A GEL TUBE: BD VACUTAINER) AND ACCOMPANIED BY A DATA FLAG. THE LABORATORY HAS A STANDARD PRACTICE TO RETEST SOME SAMPLES FROM THE SAME PATIENT USING DIFFERENT TUBES. THE 1ST REPEAT RESULT WAS 9.81 MIU/ML (TESTED IN A TUBE WITHOUT GEL: BD RED CAP). ON 21-MAR-2026: A NEW BLOOD SAMPLE (SAMPLE 2) WAS DRAWN AND TESTED, RESULTING IN THE FOLLOWING: <0.200 MIU/ML (TESTED IN A GEL TUBE: BD VACUTAINER) AND ACCOMPANIED BY A DATA FLAG. <0.200 MIU/ML (TESTED IN A TUBE WITHOUT GEL: BD RED CAP) AND ACCOMPANIED BY A DATA FLAG. SAMPLE 2 WAS SENT TO A DIFFERENT LABORATORY AND RETESTED, RESULTING IN AN HCG+SS OF <0.2 MIU/ML. ON 23-MAR-2026: SAMPLE 1 (TUBE WITHOUT GEL: BD RED CAP) WAS REPEATED, AND THE 2ND REPEAT RESULT WAS 12.9 MIU/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE RESULT OF <0.200 MIU/ML, ACCOMPANIED BY A DATA FLAG INDICATING A NEGATIVE RESULT, WAS DEEMED CORRECT AND REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24846291 ↗
• MalfunctionApr 3, 2026Incorrect Measurement; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+SS RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 145 MIU/ML. ON (B)(6) 2026, THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 23,724 MIU/ML (REPORTED AS 23,000 MIU/ML). THE SAMPLE WAS REPEATED ON THE SAME MODULE AS THE INITIAL RESULT, AND THE RESULT WAS 23,000 MIU/ML. THE SAMPLE WAS REPEATED BECAUSE THE PHYSICIAN QUESTIONED THE RESULT. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774899 ↗
• MalfunctionMar 11, 2026Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG+SS (HCG + B) ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 648 MIU/ML. THE DR. QUESTIONED THIS RESULT. ON (B)(6) 2026, THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 6428 MIU/ML AND 6333 MIU/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570685 ↗
• MalfunctionMar 6, 2026High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+SS RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1: THE INITIAL RESULT WAS 517 MUI/ML. SAMPLE 2: ON (B)(6) 2026, A NEW SAMPLE FROM THE SAME PATIENT WAS TESTED, AND THE RESULT WAS 0.200 MUI/ML WITH A DATA FLAG (REPORTED AS <1 MUI/ML). SAMPLE 3: DUE TO THE DISCREPANCY BETWEEN THE TWO SAMPLE RESULTS, A THIRD SAMPLE WAS TESTED, AND THE RESULT WAS <1 MUI/ML. ON (B)(6) 2025, THE INITIAL SAMPLE (SAMPLE 1) WAS REPEATED, AND THE RESULTS WERE 0.804 MIU/ML (REPORTED AS <1 MUI/ML) AND 0.200 MUI/ML WITH A DATA FLAG (REPORTED AS <1 MUI/ML).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24529229 ↗
• MalfunctionFeb 24, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HCG+SS RESULT FROM THE COBAS E 801 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 193 MIU/ML, AND THE REPEAT RESULT WAS 320 MIU/ML. THE REPEAT RESULT ON A COBAS PURE WAS 327 MIU/ML. ON (B)(6) 2026, THE SAMPLE WAS REPEATED ON THE E 801 AGAIN WITH RESULTS OF 333 MIU/ML AND 335 MIU/ML. A PREVIOUS RESULT FROM (B)(6) 2026 OF 241 MIU/ML WAS AVAILABLE, AND THE CUSTOMER NOTICED THE DIFFERENCE AND REPEATED THE SAMPLE TO CONFIRM THE RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428128 ↗
• MalfunctionFeb 20, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+SS RESULTS FROM THE COBAS E602 ANALYZER ON (B)(6) 2026, A PATIENT SAMPLE WAS TESTED ON THE COBAS E602 ANALYZER WITH A RESULT OF 193.1 MIU/ML. ON (B)(6) 2026, THE CLINICIAN INDICATED THAT THE RESULT WAS INCONSISTENT WITH THE PATIENT'S STATUS, AND A NEW SAMPLE WAS DRAWN. USING A COBAS PRO E801, THE RESULT FOR THE NEW SAMPLE WAS <0.1 MIU/ML. USING A COBAS PRO E801, THE ORIGINAL SAMPLE WAS REPEATED, AND THE RESULT WAS <0.1 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402152 ↗
• MalfunctionJan 5, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HCG+SS RESULT FROM THE COBAS PURE SAMPLE SUPPLY UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 22 MIU/ML, AND THE REPEAT RESULT WAS 873 MIU/ML. THE INITIAL RESULT WAS DEEMED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960064 ↗
• MalfunctionDec 23, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+SS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS <1 MIU/ML. THE ER DREW A SECOND SAMPLE 1 HOUR LATER THAT HAD A RESULT OF 26547 MIU/ML. THE ER DEPARTMENT QUESTIONED THE INITIAL RESULT. THE ORIGINAL SAMPLE WAS THEN REPEATED WITH AN AUTODILUTION, AND THE RESULT WAS 30436 MIU/ML. THIS RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876428 ↗
• MalfunctionNov 18, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG+B (HCG+B) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 4.17 MIU/ML. THE REPEAT RESULT WAS 515 MIU/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585687 ↗
• MalfunctionOct 21, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS HCG+SS ASSAY ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: SAMPLE 1: INITIAL RESULT: 60.3 IU/L. ON (B)(6) 2025: A NEW SAMPLE (SAMPLE 2) WAS DRAWN FROM THE PATIENT AND TESTED, RESULTING IN A VALUE OF <0.200 IU/L (ACCOMPANIED BY A DATA FLAG). SAMPLE 1: REPEAT RESULT: <0.200 IU/L (ACCOMPANIED BY A DATA FLAG). PATIENT 2: ON (B)(6) 2025: SAMPLE 1: INITIAL RESULT: 425 IU/L. REPEAT RESULT: 0.<200 IU/L (ACCOMPANIED BY A DATA FLAG). ON (B)(6) 2025: A NEW SAMPLE (SAMPLE 2) WAS DRAWN FROM THE PATIENT AND TESTED, RESULTING IN A VALUE OF <0.200 IU/L (ACCOMPANIED BY A DATA FLAG). THE RESULTS OF <0.200 IU/L WERE DEEMED TO BE CORRECT, AS PATIENT 1 AND PATIENT 2 WERE CONFIRMED NOT TO BE PREGNANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349702 ↗
• MalfunctionSep 18, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A FALSE NEGATIVE ELECSYS HCG+SS RESULT FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2025, THE INITIAL RESULT WAS <1 MIU/ML. ON (B)(6) 2025, THE SAMPLE WAS REPEATED AND THE RESULT WAS 74383 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085559 ↗
• MalfunctionSep 18, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS HCG+B RESULTS FROM THREE SAMPLES (TWO FROM THE SAME PATIENT) TESTED ON THE COBAS E 402 ANALYTICAL UNIT AND TWO COBAS PRO ANALYZERS. ON (B)(6) 2025: PATIENT 1 FIRST SAMPLE THE INITIAL RESULT FROM THE ANALYZER WAS 3.82 MIU/ML. THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 18.5 MIU/ML. THE SECOND REPEAT RESULT FROM THE ANALYZER WAS 18.6 MIU/ML. THE THIRD REPEAT RESULT FROM ANOTHER LABORATORY'S COBAS PRO ANALYZER WAS 19.6 MIU/ML. SECOND SAMPLE (FROM THE SAME BLOOD COLLECTION). THE RESULT FROM THE COBAS PRO ANALYZER WAS 4.06 MIU/ML. THE HIGH RESULTS WERE DEEMED CORRECT. PATIENT 2 FIRST SAMPLE ON (B)(6) 2025: THE RESULTS FROM THE COBAS PURE ANALYZER USING THE PRIMARY SAMPLE TUBE WERE 0.351 MIU/ML, 0.353 MIU/ML, AND 0.296 MIU/ML. THE RESULTS FROM THE COBAS PURE ANALYZER USING AN ALIQUOT OF THE PATIENT SAMPLE WERE 0.344 MIU/ML, 0.309 MIU/ML, AND 0.340 MIU/ML. THE RESULTS FROM THE FIRST COBAS PRO ANALYZER USING THE PRIMARY PATIENT SAMPLE TUBE WERE 43.0 MIU/ML AND 52.8 MIU/ML. THE RESULTS FROM THE SECOND COBAS PRO ANALYZER USING THE PRIMARY PATIENT SAMPLE TUBE WERE 53.9 MIU/ML AND 55.6 MIU/ML. THE RESULTS FROM THE FIRST COBAS PRO ANALYZER US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082700 ↗
• MalfunctionAug 28, 2025Low 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 ELECSYS HCG+SS ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HCG+B VALUE OF 42.3 MIU/ML. A PHYSICIAN REQUESTED A REPEAT OF THE SAMPLE. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER ON (B)(6) 2025, RESULTING IN AN HCG+B VALUE OF 15936 MIU/ML. THE REPEAT VALUE WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916189 ↗
• MalfunctionAug 18, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+SS RESULTS FROM THE COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.2 MIU/ML. THE REPEAT RESULTS WERE 32.6 MIU/ML AND 32.6 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22826238 ↗
• MalfunctionAug 12, 2025Low Test Results; Material Integrity Problem; Non Reproducible Results; Low Test Results; Material Integrity Problem; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS HCG+SS ON A COBAS PURE C 303 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN HCG+B VALUES OF 63.1 MIU/ML AND > 10000 MIU/ML WITH A DATA FLAG. THE CLIENT COMPLAINED BECAUSE THE VALUE OF 63.1 MIU/ML DID NOT MATCH THE PATIENT'S PREVIOUS RECORDS. THE SAMPLE WAS DILUTED AND REPEATED TWICE ON (B)(6) 2025, RESULTING IN HCG+B VALUES OF > 10000 MIU/ML WITH A DATA FLAG AND 18390 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786998 ↗
• MalfunctionAug 12, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+SS RESULTS FROM THE COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS NEGATIVE. NO NUMERIC RESULT WAS PROVIDED. THE REPEAT RESULT FROM ANOTHER LABORATORY WAS 22 MIU/ML (POSITIVE). THE SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER, AND THE RESULT WAS POSITIVE. NO NUMERIC RESULT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786991 ↗
• MalfunctionAug 8, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG+B (HCG + B) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 2196 MIU/ML. THIS RESULT WAS QUESTIONED BASED ON THE PATIENT¿S PREVIOUS RESULTS, AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 20.7 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751889 ↗
• MalfunctionJul 14, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+SS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE PATIENT'S HCG RESULTS WERE PERSISTENTLY LOW, WITH A POSITIVE VALUE OF APPROXIMATELY 100 MIU/ML. AS THE PATIENT WAS NOT PREGNANT, THE RESULTS DID NOT MATCH THE CLINICAL STATUS. THE CUSTOMER SUSPECTED AN INTERFERENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493161 ↗
• MalfunctionJul 7, 2025False Positive Result; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; False Positive Result; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS HCG+B RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 E 801 MODULE AND AN UNSPECIFIED ROCHE ANALYZER. THE QUALITATIVE PREGNANCY TEST FROM ANOTHER LABORATORY WAS "POSITIVE". THE INITIAL RESULT FROM THE MODULE WAS <0.20 MUI/ML. THE RESULT FROM ANOTHER LABORATORY FOR VERIFICATION WAS "NEGATIVE". THE REPEAT RESULT FROM ANOTHER ROCHE ANALYZER WAS <0.20 MUI/ML. A "NEGATIVE" RESULT WAS REPORTED TO THE PATIENT BASED ON THIS RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411092 ↗
• MalfunctionJun 16, 2025Incorrect Measurement; Low Test Results; Non Reproducible Results; Incorrect Measurement; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+B RESULTS FOR 1 PATIENT ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 25.6 MIU/ML. A NEW SAMPLE WAS OBTAINED FROM THE PATIENT, AND THE RESULT WAS 3,000 MIU/ML. THE PHYSICIAN QUESTIONED THE RESULT FROM THE INITIAL SAMPLE AND REQUESTED THAT THE SAMPLE BE REPEATED. ON (B)(6) 2025, THE INITIAL SAMPLE WAS REPEATED, AND THE RESULTS WERE 1864 MIU/ML AND 1877 MIU/ML. THE INITIAL SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 1941 MIU/ML. THE RESULT OF 1864 MIU/ML WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212351 ↗
• MalfunctionJun 10, 2025High Test Results; Low Test Results; Non Reproducible Results; High Test Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS HCG+B RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS PURE E 402 ANALYTICAL UNIT. PATIENT SAMPLE 1: THE INITIAL RESULT WAS 4.05 MIU/ML. THE REPEAT RESULT WAS 39.2 MIU/ML. PATIENT SAMPLE 2: THE INITIAL RESULT FROM THE ANALYZER WAS 25.9 MIU/ML. THE REPEAT RESULT FROM A COBAS C 601 WAS 6.99 MIU/ML. THE REPEAT RESULT FROM THE ANALYZER WAS <3 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174911 ↗
• MalfunctionJun 5, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS HCG+BETA (HCG+B) ASSAY ON A COBAS E801 MODULE. INITIAL RESULT: 546 MIU/ML. SINCE A MISCARRIAGE WAS SUSPECTED, THE SAMPLE WAS THEN REPEATED. 1ST REPEAT RESULT: 10000 MIU/ML WITH A DATA FLAG. 2ND REPEAT RESULT: 60267 MIU/ML, AND IT WAS CONSIDERED A GOOD RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150689 ↗
• MalfunctionMay 15, 2025False Negative Result; Low Test Results; Non Reproducible Results; False Negative Result; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF A LOW RESULT NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG+B (HCG+B) ON A COBAS E 402 ANALYTICAL UNIT. THE RESULT FROM THE E402 ANALYZER WAS < 1 MIU/ML. THE PHYSICIAN QUESTIONED THIS RESULT. THE PATIENT HAD BEEN TESTED "A FEW DAYS" BEFORE THE LOW RESULT, AND THE RESULT WAS "POSITIVE." THE ACTUAL RESULT WAS NOT PROVIDED. THE PATIENT WAS TESTED AGAIN "A FEW DAYS" AFTER THE LOW RESULT, AND THE RESULT WAS "POSITIVE." THE ACTUAL RESULT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028257 ↗
• MalfunctionApr 18, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR THREE SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH ELECSYS HCG+B ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER ALLEGES THAT THE CHANGE IN RESULTS BETWEEN THE FIRST SAMPLE AND THE SUBSEQUENT 2 SAMPLES WAS NOT CLINICALLY POSSIBLE FOR THE PATIENT. THE FIRST SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN HCG+B VALUE OF 2605 MIU/ML. A SECOND SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN HCG+B VALUE OF < 0.200 MIU/ML WITH A DATA FLAG ON (B)(6) 2025. A THIRD SAMPLE COLLECTED FROM THE PATIENT RESULTED IN AN HCG+B VALUE OF < 0.200 MIU/ML WITH A DATA FLAG ON (B)(6) 2025. THE CUSTOMER REPEATED THE FIRST SAMPLE ON (B)(6) 2025 AND IT RESULTED IN AN HCG+B VALUE OF 2531 MIU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867484 ↗
• MalfunctionMar 4, 2025Low 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 ELECSYS HCG+SS ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN HCG+B VALUE OF < 0.200 MIU/ML WITH A DATA FLAG. THIS VALUE WAS REPORTED IN THE CUSTOMER'S LABORATORY INFORMATION SYSTEM AS < 2.00 MIU/ML. THE PATIENT PREVIOUSLY TESTED POSITIVE FOR PREGNANCY. THE PATIENT WAS NOT SATISFIED WITH THE INITIAL RESULT, SO THE PATIENT WENT TO ANOTHER HOSPITAL WHERE THEY WERE TESTED WITH AN UNKNOWN METHOD AND HAD A POSITIVE HCG+B RESULT. THE PATIENT'S SAMPLE WAS REPEATED ON (B)(6) 2025, RESULTING IN AN HCG+B VALUE OF > 10000 MIU/ML WITH A DATA FLAG. THE SAMPLE WAS DILUTED 1:100 AND REPEATED, RESULTING IN A VALUE OF 90827 MIU/ML ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516538 ↗