Elecsys Rubella IgG 07027770190Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04015630940240), received between Jan 25, 2019 and Mar 25, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “High Test Results” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS RUBELLA IGG RESULTS FOR THREE PATIENT SAMPLES TESTED ON A COBAS E 402 ANALYTICAL UNIT COMPARED TO A REFERENCE LAB. SAMPLE 1: THE INITIAL RESULT WAS 40.5 IU/ML (POSITIVE). THE REPEAT RESULT AT A REFERENCE LAB WAS NEGATIVE. SAMPLE 2: THE INITIAL RESULT WAS 45 IU/ML (POSITIVE). THE REPEAT RESULT AT A REFERENCE LAB WAS NEGATIVE. SAMPLE 3: THE INITIAL RESULT WAS 46.2 IU/ML (POSITIVE). THE REPEAT RESULT AT A REFERENCE LAB WAS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686330 ↗
• MalfunctionFeb 3, 2026False Positive Result; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS RUBELLA IGG RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2025, THE PATIENT'S RESULT USING THE DIASORIN METHOD WAS NEGATIVE. IN (B)(6) 2025 (UNSPECIFIED DATE), THE PATIENT'S RESULT IN A DIFFERENT LABORATORY (UNSPECIFIED METHOD) WAS "DOUBTFUL / BORDERLINE POSITIVE". ON (B)(6) 2025, THE PATIENT'S ELECSYS RUBELLA IGG RESULT WAS 35.6 UI/ML (POSITIVE). ON (B)(6) 2026, THE PATIENT'S RESULT USING THE DIASORIN METHOD WAS NEGATIVE. THE ELECSYS RUBELLA IGG RESULT FOR THIS SAMPLE WAS 27 UI/ML (POSITIVE). THE SAMPLE WAS TESTED IN ANOTHER LABORATORY AND WAS FOUND TO BE NON-REACTIVE FOR RUBELLA IGG ANTIBODIES (NO METHOD PROVIDED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247897 ↗
• MalfunctionNov 21, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS RUBELLA IGG RESULT FOR ONE PATIENT FROM THE COBAS E 801 ANALYTICAL UNIT COMPARED TO THE RESULTS FROM ABBOTT ALINITY AT OTHER LABORATORIES. ON (B)(6) 2025, THE RESULT FROM THE COBAS E 801 WAS 31.4 IU/ML (IMMUNE). RESULTS FROM ABBOTT ALINITY USING THE SAME SAMPLE: ON (B)(6) 2015: 5.6 IU/ML (NON-IMMUNE). ON (B)(6) 2015: 5.5 IU/ML (NON-IMMUNE). ON (B)(6) 2015: 5.8 IU/ML (NON-IMMUNE). ON (B)(6) 2015: 6.5 IU/ML (NON-IMMUNE). ON (B)(6) 2015: 6.1 IU/ML (NON-IMMUNE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619599 ↗
• MalfunctionNov 20, 2025False Positive Result; False Positive Result

  WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE HIGH RESULTS FOR 3 SAMPLES FROM 2 PATIENTS TESTED WITH ELECSYS RUBELLA IGG ASSAY ON A COBAS PRO SSU ANALYZER. PATIENT 1: SAMPLE 1 WAS TESTED ON (B)(6) 2025: ELECSYS RUBELLA IGG RESULT: ABOUT 12 IU/ML AND INTERPRETED AS REACTIVE. THE EXACT VALUE WAS NOT PROVIDED. CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA FROM ABBOTT) RESULT: 3.5 AND INTERPRETED AS NEGATIVE. THE UNIT OF MEASUREMENT WAS NOT PROVIDED. PATIENT 2 WAS TESTED ON (B)(6) 2025: ELECSYS RUBELLA IGG RESULT: 17.1 IU/ML AND INTERPRETED AS REACTIVE. CMIA RUBELLA IGG RESULT: 2.1 U/ML AND INTERPRETED AS NON-REACTIVE. ELFA RUBELLA IGG RESULT: 2.0 U/ML AND INTERPRETED AS NON-REACTIVE. ELECSYS RUBELLA IGM RESULT: NON-REACTIVE. THE SAMPLE WAS REPEATED ON (B)(6) 2025, AND THE ELECSYS RUBELLA IGG RESULT WAS 19.3 IU/ML AND INTERPRETED AS REACTIVE. PATIENT 1: SAMPLE 2 WAS TESTED ON (B)(6) 2025: ELECSYS RUBELLA IGG RESULT: 11.2 IU/ML AND INTERPRETED AS REACTIVE. CMIA IGG RESULT: 3.3 U/ML AND INTERPRETED AS NEGATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607426 ↗
• MalfunctionNov 12, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS RUBELLA IGG ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE RESULTED IN A RUBELLA IGG VALUE OF 5.54 IU/ML (NEGATIVE). THE RESULT CONTRADICTED THE PATIENT'S POSITIVE HISTORY, SO THE SAMPLE WAS REPEATED ON A LIAISON SYSTEM, RESULTING IN A POSITIVE OUTCOME CONSISTENT WITH THE PATIENT'S HISTORY. RUBELLA IGG VALUES WERE CONSISTENTLY LOW WHEN REPEATED WITH THE ROCHE ASSAY. NO SPECIFIC REPEAT VALUES WERE PROVIDED OTHER THAN A VALUE OF 5.85 IU/ML (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23535510 ↗
• MalfunctionAug 11, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE POSITIVE ELECSYS RUBELLA IGG ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2025, THE INITIAL RESULT FROM THE ANALYZER WAS 19.40 UI/ML (POSITIVE). THE PATIENT SAMPLE WAS SENT OUT TO TWO OTHER LABORATORIES: ON (B)(6) 2025, THE REPEAT RESULT FROM THE FIRST COMPETITOR ANALYZER WAS 2.6 UI/ML (NEGATIVE). ON (B)(6) 2025, THE REPEAT RESULT FROM THE SECOND COMPETITOR ANALYZER WAS 5.64 UI/ML (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22776019 ↗
• MalfunctionApr 22, 2025False Positive Result; False Positive Result

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR 9 PATIENT SAMPLES TESTED FOR ELECSYS RUBELLA IGG (RUBELLA IGG) ON A COBAS E 402 ANALYTICAL UNIT COMPARED TO A COBAS E801 ANALYZER AT ANOTHER LABORATORY. ON (B)(6) 2024 PATIENT 1 RESULT FROM THE E402 ANALYZER WAS 21 IU/ML (POSITIVE). THE RESULT FROM THE E801 ANALYZER WAS 7.6 IU/ML (NEGATIVE). ON (B)(6) 2024 PATIENT 2 RESULT FROM THE E402 ANALYZER WAS 15.3 IU/ML (POSITIVE). THE RESULT FROM THE E801 ANALYZER WAS 6.1 IU/ML (NEGATIVE). ON (B)(6) 2024 PATIENT 3 RESULT FROM THE E402 ANALYZER WAS 60.7 IU/ML (POSITIVE). THE RESULT FROM THE E801 ANALYZER WAS 5.6 IU/ML (NEGATIVE). ON (B)(6) 2024 PATIENT 4 RESULT FROM THE E402 ANALYZER WAS 14 IU/ML (POSITIVE). THE RESULT FROM THE E801 ANALYZER WAS 4.8 IU/ML (NEGATIVE). ON (B)(6) 2024 PATIENT 5 RESULT FROM THE E402 ANALYZER WAS 21.7 IU/ML (POSITIVE). THE RESULT FROM THE E801 ANALYZER WAS 6.9 IU/ML (NEGATIVE). ON (B)(6) 2024 PATIENT 6 RESULT FROM THE E402 ANALYZER WAS 40.2 IU/ML (POSITIVE). THE RESULT FROM THE E801 ANALYZER WAS 3.5 IU/ML (NEGATIVE). ON (B)(6) 2024 PATIENT 7 RESULT FROM THE E402 ANALYZER WAS 45.3 IU/ML (POSITIVE). THE RESULT FROM THE E801 ANALYZER WAS 7.4 IU/ML (NEGATIVE). ON (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881700 ↗
• MalfunctionFeb 21, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS RUBELLA IGG ON A COBAS E 801 MODULE. THE SAMPLE INITIALLY RESULTED IN A RUBELLA IGG VALUE OF 4.94 UI/ML (NEGATIVE) WHEN TESTED USING THE ROCHE METHOD. THE SAMPLE WAS REPEATED ON A LIAISON XL ANALYZER ON (B)(6) 2025, RESULTING IN A RUBELLA IGG VALUE OF 13.90 UI/ML (POSITIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432204 ↗
• MalfunctionNov 15, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS RUBELLA IGG RESULTS FROM 24 PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. PLEASE REFER TO THE ATTACHMENT (B)(6) IN THE MEDWATCH FOR THE TABLE CONTAINING THE EXAMPLES OF QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695423 ↗
• MalfunctionOct 10, 2024False Negative Result; Low Test Results; False Negative Result; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS RUBELLA IGG IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2024, THE INITIAL RUBELLA IGG RESULT WAS 8.90 IU/ML, INTERPRETED AS NON-REACTIVE. THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE ELISA TESTING WAS PERFORMED AND THE RUBELLA IGG RESULT WAS REACTIVE. ON (B)(6) 2024, THE PATIENT HAD A SAMPLE WITH A RUBELLA IGG RESULT OF 8.65 IU/ML, INTERPRETED AS NON-REACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417370 ↗
• MalfunctionOct 2, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS RUBELLA IGG RESULTS FOR 1 PATIENT ON A COBAS 8000 E 801 MODULE. THE PATIENT'S ELECSYS RUBELLA IGG RESULT WAS 6.95 IU/ML (NON-REACTIVE). THIS RESULT WAS CONSIDERED TO BE A FALSE NEGATIVE. THE SAMPLE WAS TESTED USING THE MIKROGEN RUBELLA IGG METHOD AND THE ANTI-E1 REACTIVITY WAS DETECTED AND THE PATIENT WAS CONSIDERED IMMUNE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352681 ↗
• MalfunctionAug 6, 2024False Positive Result; False Positive Result

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS RUBELLA IGG ON A COBAS E 801 MODULE. THE SAMPLE RESULTED IN A RUBELLA IGG VALUE OF 14 IU/ML (REACTIVE) WHEN TESTED ON THE E 801 ANALYZER. THE SAMPLE WAS REPEATED ON A VIDAS INSTRUMENT, RESULTING IN A NEGATIVE RUBELLA IGG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921430 ↗
• MalfunctionOct 17, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RUBELLA IGG ELECSYS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 71.8 MUI/ML (POSITIVE). THE RESULT ION ANOTHER LABORATORY USING ABBOTT WAS NEGATIVE. THE SAMPLE WAS REPEATED ON TWO COBAS ANALYZER AND THE RESULTS WERE 69.8 MUI/ML AND 64.3 MUI/ML (POSITIVE). NO INFORMATION WAS PROVIDED TO DETERMINE IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948963 ↗
• MalfunctionJun 6, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS RUBELLA IGG IMMUNOASSAY RESULTS FOR 4 PATIENT SAMPLES ON A COBAS PURE E 402 ANALYTICAL UNIT. FOR PATIENT 1, THE INITIAL RUBELLA IGG RESULT WAS 63.6 IU/ML, INTERPRETED AS POSITIVE. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND THE RESULT WAS NEGATIVE. FOR PATIENT 2, THE INITIAL RUBELLA IGG RESULT WAS 50.1 IU/ML, INTERPRETED AS POSITIVE. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND THE RESULT WAS NEGATIVE. FOR PATIENT 3, THE INITIAL RUBELLA IGG RESULT WAS 23.2 IU/ML, INTERPRETED AS POSITIVE. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND THE RESULT WAS NEGATIVE. FOR PATIENT 4, THE INITIAL RUBELLA IGG RESULT WAS 52.4 IU/ML, INTERPRETED AS POSITIVE. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY AND THE RESULT WAS NEGATIVE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE TESTING METHOD USED BY THE REFERENCE LABORATORY WAS REQUESTED BUT NOT PROVIDED. THE ANALYZER SERIAL NUMBER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073250 ↗
• MalfunctionApr 3, 2023High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED POSITIVE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS RUBELLA IGG RUBELLA IGG ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE E801 ANALYZER WAS 155 IU/ML POSITIVE. THE REPEAT ON THE SAME ANALYZER WAS 174 IU/ML POSITIVE. THE SAMPLE WAS SENT TO AN EXTERNAL LABORATORY FOR TESTING BY THE VIDAS METHOD AND THE RUBELLA IGG RESULT WAS 9.74 IU/ML NEGATIVE. IT IS NOT KNOWN IF THE QUESTIONABLE POSITIVE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E801 ANALYZER SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16666635 ↗
• MalfunctionDec 15, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS RUBELLA IGG IMMUNOASSAY RESULTS FOR 3 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A SIEMENS ASSAY. FOR PATIENT 1, THE ELECSYS RUBELLA IGG RESULT WAS 17.2 IU/ML, INTERPRETED AS POSITIVE. THE SIEMENS ASSAY RESULT WAS NEGATIVE. FOR PATIENT 2, THE ELECSYS RUBELLA IGG RESULT WAS 91.9 IU/ML, INTERPRETED AS POSITIVE. THE SIEMENS ASSAY RESULT WAS NEGATIVE. FOR PATIENT 3, THE ELECSYS RUBELLA IGG RESULT WAS 27.2 IU/ML, INTERPRETED AS POSITIVE. THE SIEMENS ASSAY RESULT WAS NEGATIVE. THE INITIAL ELECSYS ASSAY RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E801 ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987899 ↗
• MalfunctionAug 15, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE RUBELLA IGG ELECSYS FROM COBAS E 801 MODULE SERIAL NUMBER 1785-06. THE RESULT WAS 42 UI/L (REACTIVE). THE RESULT BY VIDAS METHOD WAS 7 UI/ML (NON-REACTIVE). THE RESULT BY ABBOTT ALINITY WAS 4.7 UI/ML (NON-REACTIVE) THE RESULT BY DIASORIN LIAISON WAS (NON-REACTIVE). THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224974 ↗
• MalfunctionFeb 2, 2022False Negative Result; False Negative Result

  THE INITIAL REPORTER STATED THEY RECEIVED FALSE NEGATIVE RESULTS FOR ONE PATIENT TESTED WITH THE ELECSYS RUBELLA IGG IMMUNOASSAY ON A COBAS E 801 MODULE SERIAL NUMBER (B)(4). THE REPORTER STATED THEY RECEIVED REPRODUCIBLE NEGATIVE RESULTS ON SEVERAL SAMPLES FROM THE SAME PATIENT THAT WHEN TESTED ON A DIASORIN, A CENTAUR AND AN IMMULITE RESULTED IN REACTIVE RESULTS. THE PATIENT¿S E801 RESULT ON (B)(6) 2021 WAS 4.36 IU/ML (NEGATIVE). THE PATIENT¿S E801 RESULT ON (B)(6) 2021 WAS 4.08 IU/ML (NEGATIVE). THE PATIENT¿S E801 RESULT ON (B)(6) 2021 WAS 2.60 IU/ML (NEGATIVE). THE PATIENT¿S DIASORIN RESULT ON (B)(6) 2021 WAS 41.0 IU/ML (REACTIVE). THE PATIENT¿S CENTAUR RESULT ON (B)(6) 2021 WAS 22.0 IU/ML (REACTIVE). THE PATIENT¿S IMMULITE RESULT ON (B)(6) 2021 WAS 17 IU/ML (REACTIVE). THE PATIENT¿S E801 RESULT ON (B)(6) 2021 WAS 1.74 IU/ML (NEGATIVE). THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13422224 ↗
• MalfunctionJan 28, 2022False Positive Result; False Positive Result

  THERE WAS A COMPLAINT OF QUESTIONABLE ELECSYS RUBELLA IGG RESULTS FOR 1 PATIENT TESTED WITH A COBAS E801 MODULE SERIAL NUMBER (B)(4). THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY TO THE PHYSICIAN. THE PATIENT¿S SAMPLE WAS ALSO TESTED WITH A DIASORIN AND ANOTHER UNKNOWN METHOD. THE PATIENT¿S E801 RESULT ON (B)(6) 2021 WAS 72.1 UI/I, REACTIVE. THE PATIENT¿S E801 RESULT ON (B)(6) 2021 WAS 59.4 UI/I, REACTIVE. THE PATIENT¿S DIASORIN RESULT ON (B)(6) 2021 WAS 5.0 UI/I, NEGATIVE. THE PATIENT¿S UNKNOWN METHOD RESULT WAS NEGATIVE. THE ELECSYS RUBELLA IGG USED ON (B)(6) 2021 WAS LOT 58675801 AND HAD AN EXPIRATION DATE OF 31-OCT-2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13383690 ↗
• MalfunctionSep 2, 2021High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RUBELLA IGG ELECSYS RESULTS FROM COBAS E 801 MODULE SERIAL NUMBER (B)(4). FROM THE FIRST SAMPLE FROM THE PATIENT, THE RUBELLA IGG RESULT WAS 53.5 UI/ML (POSITIVE). THE RESULT FROM ANOTHER LABORATORY USING VIDAS BIOMÉRIEUX WAS NEGATIVE. ON (B)(6) 2021, A SECOND SAMPLE DRAWN FROM THE PATIENT AT THE SAME TIME AS THE FIRST SAMPLE WAS TESTED. THE RUBELLA IGG RESULT WAS 54.2 UI/ML (POSITIVE). THE RESULT FROM ANOTHER LABORATORY WAS NEGATIVE. IT WAS NOT KNOWN IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12412743 ↗
• MalfunctionJan 25, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. ERRONEOUS LOW RESULTS WERE GENERATED BY THE COBAS 6000 E 601 MODULE. THE EVENTS INVOLVED A TOTAL OF TWO PATIENTS WITH THE FOLLOWING: TWO ERRONEOUS RESULTS FOR THE ELECSYS RUBELLA IGG IMMUNOASSAY. THE PATIENTS' AGES RANGED FROM 32 TO 35 YEARS. THE PATIENTS' WEIGHTS WERE REQUESTED, BUT NOT PROVIDED. THERE WAS ONE FEMALE. THE GENDER OF THE OTHER PATIENT WAS REQUESTED, BUT NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED, BUT NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Information

  MAUDE report 8278114 ↗