Dimension Vista® Flex® reagent cartridge BHCG 10445107Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00842768015540), received between Aug 11, 2017 and Apr 13, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “High Test Results” (29 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026High Test Results

  THE CUSTOMER REPORTED THAT THE FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES WITH ERROR FLAGS ON A DIMENSION VISTA 1500 SYSTEM. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA 1500 SYSTEM. THE REPEAT RESULTS MATCHED WITH CLINICAL HISTORY AND WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BHCG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24856133 ↗
• MalfunctionApr 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED TO SIEMENS THAT AN ERRONEOUS BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT ON A PATIENT SAMPLE WAS OBTAINED ON A DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM. THE REPROCESSED RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THE CUSTOMER DID NOT PROVIDE THE PATIENT SAMPLE DATA TO SIEMENS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS BHCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854712 ↗
• MalfunctionSep 19, 2023High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA® 500 INTELLIGENT LAB SYSTEM. THE FALSELY ELEVATED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. NEW SAMPLES FROM THE SAME PATIENT WERE DRAWN AND PROCESSED ON AN ALTERNATE DIMENSION VISTA® 500 INTELLIGENT LAB SYSTEM ON (B)(6) 2023, OBTAINING FALSELY ELEVATED RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774495 ↗
• MalfunctionSep 19, 2023High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA® 500 INTELLIGENT LAB SYSTEM. THE FALSELY ELEVATED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. ADDITIONALLY, A SAMPLE FROM THE SAME PATIENT WAS DRAWN AND PROCESSED ON AN ALTERNATE DIMENSION VISTA® 500 INTELLIGENT LAB SYSTEM ON (B)(6) 2023 OBTAINING A FALSELY ELEVATED RESULT. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT ON (B)(6) 2023 AND PROCESSED ON THE SAME DIMENSION VISTA® 500 INTELLIGENT LAB SYSTEM, OBTAINING A FALSELY ELEVATED RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774490 ↗
• MalfunctionSep 19, 2023High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA® 500 INTELLIGENT LAB SYSTEM. THE FALSELY ELEVATED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. ADDITIONALLY, A SAMPLE FROM THE SAME PATIENT WAS DRAWN AND PROCESSED ON AN ALTERNATE DIMENSION VISTA® 500 INTELLIGENT LAB SYSTEM ON 08-AUG-2023 WHICH OBTAINED A FALSELY ELEVATED RESULT. A SAMPLE FROM THE SAME PATIENT WAS DRAWN AND PROCESSED ON THE SAME DIMENSION VISTA® 500 INTELLIGENT LAB SYSTEM ON 16-AUG-2023, OBTAINING A FALSELY ELEVATED RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774462 ↗
• MalfunctionOct 7, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). NEW SAMPLES WERE PROCESSED ON LATER DATES ON ALTERNATE NON-SIEMENS SYSTEMS AND LOWER, NEGATIVE RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED. THE PATIENT WAS ADMINISTERED METHOTREXATE ON THE BASIS OF THE ELEVATED BHCG RESULT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE FALSELY ELEVATED BHCG RESULT OR THE METHOTREXATE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15566284 ↗
• MalfunctionOct 7, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). NEW SAMPLES WERE PROCESSED ON LATER DATES ON ALTERNATE NON-SIEMENS SYSTEMS AND LOWER, NEGATIVE RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BHCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561599 ↗
• MalfunctionOct 7, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). NEW SAMPLES WERE PROCESSED ON THE SAME AND LATER DATES ON ALTERNATE NON-SIEMENS SYSTEMS AND LOWER, NEGATIVE RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BHCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561594 ↗
• MalfunctionOct 7, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME DAY ON AN ALTERNATE NON-SIEMENS SYSTEMS AND LOWER, NEGATIVE RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BHCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561592 ↗
• MalfunctionOct 7, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). NEW SAMPLES WERE PROCESSED ON LATER DATES ON ALTERNATE NON-SIEMENS SYSTEMS AND LOWER, NEGATIVE RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BHCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561590 ↗
• MalfunctionOct 7, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). NEW SAMPLES WERE PROCESSED ON LATER DATES ON ALTERNATE NON-SIEMENS SYSTEMS AND LOWER, NEGATIVE RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BHCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561589 ↗
• MalfunctionOct 7, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE RESULT WAS REPORTED TO THE PHYSICIAN(S). NEW SAMPLES WERE PROCESSED ON LATER DATES ON ALTERNATE NON-SIEMENS SYSTEMS AND LOWER, NEGATIVE RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BHCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561587 ↗
• MalfunctionOct 7, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). NEW SAMPLES WERE PROCESSED ON LATER DATES ON ALTERNATE NON-SIEMENS SYSTEMS AND LOWER, NEGATIVE RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED BHCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561582 ↗
• MalfunctionFeb 4, 2022High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA 1500 SYSTEM. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS THEN REPROCESSED ON AN ALTERNATE ATELLICA IM 1300 SYSTEM, AND A NON-SIEMENS SYSTEM, AND LOWER BHCG RESULTS, CONSIDERED CORRECT WERE OBTAINED. ADDITIONALLY, A QUALITATIVE KIT TESTING WAS PERFORMED FOR THE SAME PATIENT SAMPLE, AND A NEGATIVE RESULT WAS OBTAINED. THE LOWER REPROCESSED RESULT FROM THE NON-SIEMENS SYSTEM WAS REPORTED AND THE OTHER REPROCESSED RESULT WAS MADE KNOWN TO THE PHYSICIAN(S). NO CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450927 ↗
• MalfunctionApr 9, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG)PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA® 1500 SYSTEM. THE INITIAL RESULT WAS REPORTED AND LATER QUESTIONED BY THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED DISCORDANT BHCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645572 ↗
• MalfunctionApr 9, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA® 1500 SYSTEM. THE INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE SAME SAMPLE WAS SPLIT AND REPROCESSED ON THE SAME DIMENSION VISTA INSTRUMENT AND ALSO SENT OUT FOR TESTING AT TWO EXTERNAL LABORATORIES. THE RESULTS FROM THE EXTERNAL LABORATORIES RESULTED LOWER AND WERE CONSIDERED TRUE FOR THE PATIENT. BOTH RESULTS FROM THE EXTERNAL LABORATORIES MATCHED EACH OTHER AND WERE REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED DISCORDANT BHCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645561 ↗
• MalfunctionApr 9, 2021High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) PATIENT SAMPLE RESULT WAS OBTAINED ON A DIMENSION VISTA® 1500 SYSTEM. THE INITIAL RESULT WAS REPORTED AND LATER QUESTIONED BY THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED DISCORDANT BHCG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645547 ↗
• MalfunctionJul 12, 2019Incorrect Measurement; Incorrect Measurement

  A DISCORDANT HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 1500 SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED UNDILUTED ON THE SAME DAY ON AN ALTERNATE DIMENSION VISTA AND A LOWER RESULT WAS OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BHCG RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785846 ↗
• MalfunctionMay 18, 2018High Test Results; High Test Results

  A DISCORDANT ELEVATED HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN BUT WAS QUESTIONED BY THE CUSTOMER WHO STATED THE ELEVATED RESULT WAS HIGHER THAN EXPECTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7527121 ↗
• MalfunctionApr 30, 2018High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED BETA HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA INSTRUMENT. THE SAMPLE WAS REPEATED ON AN ALTERNATE VISTA INSTRUMENT TO CONFIRM THE INITIAL HIGH RESULT. THE RESULT WAS REPORTED TO THE HEALTH CARE PRACTITIONER (S) WHO QUESTIONED THE RESULT. THERE WAS NO KNOWN IMPACT ON PATIENT TREATMENT OR CARE AND NO ALLEGED PATIENT HARM DUE TO THE DISCORDANT ELEVATED BHCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7472359 ↗
• MalfunctionAug 24, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN. THE RESULT WAS QUESTIONED WHEN SAMPLES FROM THE PATIENT WERE FOUND NEGATIVE BY MULTIPLE ALTERNATE, NON-SIEMENS METHODOLOGIES. THE PATIENT WAS TREATED WITH METHOTREXATE. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED BHCG RESULT OR METHOTREXATE TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6818678 ↗
• MalfunctionAug 24, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN. THE RESULT WAS QUESTIONED WHEN SAMPLES FROM THE PATIENT WERE FOUND NEGATIVE BY MULTIPLE ALTERNATE, NON-SIEMENS METHODOLOGIES. THE PATIENT WAS TREATED WITH METHOTREXATE. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED BHCG RESULT OR METHOTREXATE TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6817557 ↗
• MalfunctionAug 24, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN. THE RESULT WAS QUESTIONED WHEN SAMPLES FROM THE PATIENT WERE FOUND NEGATIVE BY MULTIPLE ALTERNATE, NON-SIEMENS METHODOLOGIES. THE PATIENT WAS TREATED WITH METHOTREXATE. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED BHCG RESULT OR METHOTREXATE TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6817468 ↗
• MalfunctionAug 24, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN. THE RESULT WAS QUESTIONED WHEN SAMPLES FROM THE PATIENT WERE FOUND NEGATIVE BY MULTIPLE ALTERNATE, NON-SIEMENS METHODOLOGIES. THE PATIENT WAS TREATED WITH METHOTREXATE. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED BHCG RESULT OR METHOTREXATE TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6817420 ↗
• MalfunctionAug 24, 2017High Test Results; High Test Results

  A DISCORDANT FALSELY ELEVATED HUMAN CHORIONIC GONADOTROPIN (BHCG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA 1500 INSTRUMENT. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN. THE RESULT WAS QUESTIONED WHEN SAMPLES FROM THE PATIENT WERE FOUND NEGATIVE BY MULTIPLE ALTERNATE, NON-SIEMENS METHODOLOGIES. THE PATIENT WAS TREATED WITH METHOTREXATE. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED BHCG RESULT OR METHOTREXATE TREATMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6817413 ↗