MTS MTS080515Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10758750005932), received between Nov 22, 2022 and Mar 30, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026False Positive Result

  (B)(4) / RA613859 ON (B)(6) 2026, THE CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE D(RH1) TYPING RESULTS FOR A PATIENT SAMPLE USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 082925037-07 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (B)(6). COMPLAINANT/COMPLAINT REPORTER: (B)(6) DATE OF EVENT: 03MAR2026; REPORTED ON THE SAME DAY REAGENTS: MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 082925037-07, EXPIRATION DATE: 26JUN2026, DATE OF MANUFACTURE: 26SEP2025 PATIENT INFORMATION: HISTORY OF BLOOD TYPE O NEGATIVE. THE PATIENT IS ON HEMODIALYSIS AND WAS TRANSFUSED TWO O NEGATIVE DONOR UNITS FOLLOWING THE REPORTED EVENT. THE PATIENT STATED THEY DID NOT HAVE PRIOR RECENT TRANSFUSIONS. CUSTOMER STATES THIS IS A FREQUENTLY TRANSFUSED PATIENT. LAST TRANSFUSION AT REPORTING FACILITY OCCURRED IN 2020. THE CUSTOMER REPORTED THAT THIS PATIENT SAMPLE WAS TESTED ON (B)(6) 2026 FOR D(RH1) TYPING USING ORTHO MTS A/B/D MONOCLONAL GROUPING & REVERSE CARD LOT 082925037-07 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (B)(6) AND THAT THEY HAD OBTAINED A POSITIVE REACTION (4+ REACTION STRENGTH)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719548 ↗
• MalfunctionMar 11, 2026False Positive Result

  (B)(4) / (B)(6)ON (B)(6) 2026, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTRE (GTSC) TO REPORT WHAT WAS DESCRIBED AS A DISCREPANCY IN RESULTS IN ABO FORWARD TYPING FOR A PATIENT USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD (LOTS NOT PROVIDED) IN CONJUNCTION WITH THEIR ORTHO VISION ID MTS ANALYZER, (B)(4) (SOFTWARE VERSION NOT PROVIDED). DATE OF EVENT: 10 JULY 2025, REPORTED ON (B)(6)2026 COMPLAINANT/COMPLAINT REPORTER: CHRISTINE GALLARDO - LABORATORY SUPERVISOR REAGENTS: MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARDS (LOTS NOT PROVIDED) PATIENT HISTORY: NOT PROVIDED. THE CUSTOMER REPORTED THAT, ON THE FOLLOWING DATES, THEY HAD TESTED SAMPLES FROM THE SAME PATIENT FOR ABO FORWARD TYPING USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARDS (LOTS NOT PROVIDED) IN CONJUNCTION WITH THEIR ORTHO VISION ID MTS ANALYZERS (B)(4) AND (B)(4), AND THAT THEY HAD OBTAINED THE FOLLOWING RESULTS: - (B)(6) 2024: PATIENT RESULT STORED ON LIS AS O RHD POSITIVE ON 5(B)(4) (SAMPLE ID (B)(6)) - (B)(6) 2025: PATIENT RESULT STORED ON LIS AS B(ABO2) RHD POSITIVE ON (B)(4) (SAMPLE ID (B)(6)) - (B)(6) 2026: PATIENT RESULT OBTAINED O RHD POSITIVE AT AN ALTERNATE FACILITY. NO FURTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570788 ↗
• MalfunctionFeb 10, 2026False Negative Result

  REPORT 2 OF 2 (B)(4) ON 21JAN2026, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT FALSE NEGATIVE RESULTS FOR A PATIENT WHEN PERFORMING ABO-RH FORWARD TYPING UTILIZING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOTS 041625037-18 AND 042525037-19 ON THE ORTHO VISION SWIFT ID-MTS ANALYZERS (50004050 AND 50004570). COMPLAINANT: (B)(6). DATE OF EVENT: 07SEP2025, REPORTED ON 21JAN2026. REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 041625037-18, EXPIRATION: 28FEB2026, MANUFACTURE: 28MAY2025 MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 042525037-19, EXPIRATION: 11MAR2026, MANUFACTURE: 11JUN2025 INSTRUMENTS: ORTHO VISION SWIFT ID-MTS ANALYZER, (B)(6), SW VERSION 5.16.0 LOCATED AT COMPLAINANT SITE (B)(6) (IMMUNOHEMATOLOGY REFERENCE LABORATORY- IRL) ORTHO VISION SWIFT ID-MTS ANALYZER, (B)(6), SW VERSION 5.16.0 LOCATED AT (B)(6) HOSPITAL PATIENT INFORMATION: 46-YEAR-OLD AFRICAN AMERICAN FEMALE WITH A DIAGNOSIS OF MENOMETRORRHAGIA, HEMOGLOBIN 4.7G/DL AND HEMATOCRIT 15.2%. TRANSFUSED WITH ONE O NEGATIVE EMERGENCY-RELEASED RBC UNIT ON (B)(6). PRIOR PATIENT HISTORY OF BLOOD TYPE OR TRANSFUSION WAS NOT PROVIDED. TE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308473 ↗
• MalfunctionFeb 10, 2026False Negative Result

  REPORT 1 OF 2 (B)(4) / (B)(6) ON (B)(6) 2026, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT FALSE NEGATIVE RESULTS FOR A PATIENT WHEN PERFORMING ABO-RH FORWARD TYPING UTILIZING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOTS 041625037-18 AND 042525037-19 ON THE ORTHO VISION SWIFT ID-MTS ANALYZERS (B)(4). COMPLAINANT: (B)(6), LABORATORY CLIENT SERVICES MANAGER (B)(6); (B)(6) CUSTOMER# (B)(6) DATE OF EVENT: 07SEP2025, REPORTED ON 21JAN2026. REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 041625037-18, EXPIRATION: 28FEB2026, MANUFACTURE: 28MAY2025 MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 042525037-19, EXPIRATION: 11MAR2026, MANUFACTURE: 11JUN2025 INSTRUMENTS: ORTHO VISION SWIFT ID-MTS ANALYZER, (B)(4), SW VERSION 5.16.0 LOCATED AT COMPLAINANT SITE (B)(6) (IMMUNOHEMATOLOGY REFERENCE LABORATORY- IRL) (B)(6), SW VERSION 5.16.0 LOCATED AT (B)(6) HOSPITAL PATIENT INFORMATION: 46-YEAR-OLD AFRICAN AMERICAN FEMALE WITH A DIAGNOSIS OF MENOMETRORRHAGIA, HEMOGLOBIN 4.7G/DL AND HEMATOCRIT 15.2%. TRANSFUSED WITH ONE O NEGATIVE EMERGENCY-RELEASED RBC UNIT ON (B)(6) 2025. PRIOR PATIENT HISTORY OF BLOOD TYPE OR TR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308424 ↗
• MalfunctionFeb 10, 2026False Negative Result

  (B)(4) / RA613450 ON (B)(6) 2026, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT FALSE NEGATIVE RESULTS FOR A PATIENT WHEN PERFORMING ABO-RH FORWARD TYPING UTILIZING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOTS 041625037-18 AND 042525037-19 ON THE ORTHO VISION SWIFT ID-MTS ANALYZERS (B)(6). COMPLAINANT: (B)(6), LABORATORY CLIENT SERVICES MANAGER (B)(6) USA DATE OF EVENT: 07SEP2025, REPORTED ON (B)(6) 2026. REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 041625037-18, EXPIRATION: 28FEB2026, MANUFACTURE: 28MAY2025 MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 042525037-19, EXPIRATION: 11MAR2026, MANUFACTURE: 11JUN2025 INSTRUMENTS: ORTHO VISION SWIFT ID-MTS ANALYZER, (B)(6), SW VERSION 5.16.0 LOCATED AT COMPLAINANT SITE (B)(6) (IMMUNOHEMATOLOGY REFERENCE LABORATORY- IRL) ORTHO VISION SWIFT ID-MTS ANALYZER, (B)(6), SW VERSION 5.16.0 LOCATED AT (B)(6) HOSPITAL PATIENT INFORMATION: 46-YEAR-OLD AFRICAN AMERICAN FEMALE WITH A DIAGNOSIS OF MENOMETRORRHAGIA, HEMOGLOBIN 4.7G/DL AND HEMATOCRIT 15.2%. TRANSFUSED WITH ONE O NEGATIVE EMERGENCY-RELEASED RBC UNIT ON (B)(6) 2025. PRIOR PATIENT HISTORY OF BLOOD TYPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308210 ↗
• MalfunctionDec 17, 2025False Negative Result; False Negative Result

  REPORT 2 OF 2 CMS (B)(4) / RA612874 ON (B)(6) 2025, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT NEGATIVE RESULTS FOR A PATIENT WHEN PERFORMING ABO-RH FORWARD TYPING UTILIZING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 070225037-02 USING MANUAL GEL METHODOLOGY. COMPLAINANT: (B)(6) CUSTOMER# (B)(6), (B)(6) USA DATE OF EVENT: 20NOV2025, REPORTED ON THE SAME DAY. REAGENT: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 070225037-02, EXPIRATION: 16APR2026, MANUFACTURE: 16JUL2025 PATIENT INFORMATION: TWO-MONTH-OLD INFANT, WITH A HISTORY OF B D(RH1) ANTIGEN POSITIVE BLOOD TYPE. RECENTLY TRANSFUSED BEFORE THE EVENT WITH O D(RH1) ANTIGEN NEGATIVE BLOOD. THE CUSTOMER REPORTED THAT ON (B)(6) 2025, A SAMPLE FROM AN INFANT PATIENT WAS TESTED FOR ABO-RH FORWARD TYPING USING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 070225037-02, IN MANUAL GEL METHOD, AND THAT DISCREPANT NEGATIVE REACTIONS WERE OBTAINED FOR THE ANTI-B AND ANTI-D COLUMNS, AND AN ABO-RH FORWARD GROUPING TYPE OF O NEGATIVE WAS PRODUCED. THE CUSTOMER STATED THAT THE PATIENT'S BLOOD TYPE WAS QUESTIONED BY THE PATIENT'S NURSE, STATING THE PATIENT WAS TYP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828297 ↗
• MalfunctionDec 17, 2025False Negative Result; False Negative Result

  REPORT 1 OF 2 CMS (B)(4) ON 20NOV2025, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT NEGATIVE RESULTS FOR A PATIENT WHEN PERFORMING ABO-RH FORWARD TYPING UTILIZING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 070225037-02 USING MANUAL GEL METHODOLOGY. COMPLAINANT: (B)(6), USA DATE OF EVENT: 20NOV2025, REPORTED ON THE SAME DAY. REAGENT: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 070225037-02, EXPIRATION: 16APR2026, MANUFACTURE: 16JUL2025 PATIENT INFORMATION: TWO-MONTH-OLD INFANT, WITH A HISTORY OF B D(RH1) ANTIGEN POSITIVE BLOOD TYPE. RECENTLY TRANSFUSED BEFORE THE EVENT WITH O D(RH1) ANTIGEN NEGATIVE BLOOD. THE CUSTOMER REPORTED THAT ON 20NOV2025, A SAMPLE FROM AN INFANT PATIENT WAS TESTED FOR ABO-RH FORWARD TYPING USING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 070225037-02, IN MANUAL GEL METHOD, AND THAT DISCREPANT NEGATIVE REACTIONS WERE OBTAINED FOR THE ANTI-B AND ANTI-D COLUMNS, AND AN ABO-RH FORWARD GROUPING TYPE OF O NEGATIVE WAS PRODUCED. THE CUSTOMER STATED THAT THE PATIENT'S BLOOD TYPE WAS QUESTIONED BY THE PATIENT'S NURSE, STATING THE PATIENT WAS TYPED AS B POSITIVE AT A SISTER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828227 ↗
• MalfunctionOct 31, 2025False Positive Result; False Positive Result

  CMS (B)(4) / RA612560 ON 16OCT2025, A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) ABOUT WHAT WAS DESCRIBED AS DISCORDANT RESULTS FOR ONE PATIENT SAMPLE ABO-RH BLOOD TYPING USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 061325037-01 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (B)(6). COMPLAINANT: (B)(6), MEDICAL TECHNOLOGIST CUSTOMER# (B)(6) DATE OF EVENT: 15OCT2025, REPORTED ON: 16OCT2025 ANALYZER: ORTHO VISION SWIFT ID-MTS SERIAL NUMBER (B)(6), INSTALL DATE: 22MAR2022 SW VERSION: 5.16.0 REAGENT(S): MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 061325037-01, EXPIRATION DATE: 16MAR2026, DATE OF MANUFACTURE: 16JUN2025 PATIENT INFORMATION (PATIENT A): NO KNOWN HISTORY. SAMPLE ID: (B)(6), ENCRYPTED SAMPLE ID: (B)(6) THE CUSTOMER REPORTED THAT ON (B)(6) 2025, THEY HAD TESTED SAMPLE (B)(6) FROM PATIENT A FOR ABO-RH TYPING USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 061325037-01 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (B)(4) AND OBTAINED A B POSITIVE TYPING RESULT. SIMULTANEOUSLY, THE CUSTOMER HAD THE SAME SAMPLE TESTED FOR ABO-RH VERIFICATION (RE-TYPE) USING THE SAME REAGENTS WITH THE SAME ANALYZER AND THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442274 ↗
• MalfunctionSep 11, 2025False Positive Result; False Positive Result

  CMS 100434237 AND 100432974 / RA611912 ON (B)(6) 2025, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTRE (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE REACTIONS IN D(RH1) ANTIGEN TYPING FOR A PREGNANT PATIENT USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING GEL CARD LOTS 020725037-06 AND 021425037-15 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER 50004594 EQUIPPED WITH SOFTWARE VERSION 5.16.0. DATES OF EVENTS: 05 MAY AND 30 JUNE 2025 AWARENESS DATE: 14 AUGUST 2025 COMPLAINANT/COMPLAINT REPORTER: DR. (B)(6) - MEDICAL DIRECTOR REPORTED ON 14 AUGUST 2025 BY THE CUSTOMER TO ORTHO GTSC. REAGENTS: ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING GEL CARD LOT 020725037-06, EXPIRY 14 NOVEMBER 2025, MANUFACTURED 14 FEBRUARY 2025 ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING GEL CARD LOT 021425037-15, EXPIRY 18 DECEMBER 2025, MANUFACTURED 18 MARCH 2025 PATIENT HISTORY: 30 YEARS OLD, HISTORICALLY O RHD NEGATIVE DURING PATIENT'S LAST PREGNANCY IN 2024, RECORDED AS O RHD NEGATIVE AND RECEIVED RHOGAM. SHE IS CURRENTLY PREGNANT, AND AS OF 05 MAY 2025 HER ANTIBODY SCREEN WAS NEGATIVE. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT, ON (B)(6) JUN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025403 ↗
• MalfunctionSep 10, 2025False Positive Result; False Positive Result

  (B)(4) / RA611912 ON (B)(6) 2025, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTRE (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE REACTIONS IN D(RH1) ANTIGEN TYPING FOR A PREGNANT PATIENT USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING GEL CARD LOTS 020725037-06 AND 021425037-15 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER 50004594 EQUIPPED WITH SOFTWARE VERSION 5.16.0. DATES OF EVENTS: 05 MAY AND 30 JUNE 2025 AWARENESS DATE: 14 AUGUST 2025COMPLAINANT/COMPLAINT REPORTER: DR. (B)(6) - MEDICAL DIRECTOR REPORTED ON 14 AUGUST 2025 BY THE CUSTOMER TO ORTHO GTSC. REAGENTS: ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING GEL CARD LOT 020725037-06, EXPIRY 14 NOVEMBER 2025, MANUFACTURED 14 FEBRUARY 2025 ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING GEL CARD LOT 021425037-15, EXPIRY 18 DECEMBER 2025, MANUFACTURED 18 MARCH 2025 PATIENT HISTORY: 30 YEARS OLD, HISTORICALLY O RHD NEGATIVE DURING PATIENT'S LAST PREGNANCY IN 2024, RECORDED AS O RHD NEGATIVE AND RECEIVED RHOGAM. SHE IS CURRENTLY PREGNANT, AND AS OF (B)(6) 2025 HER ANTIBODY SCREEN WAS NEGATIVE. NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT, ON (B)(6) 2025, THEY HAD TESTED TWO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23021711 ↗
• MalfunctionMay 29, 2025False Negative Result; False Negative Result

  (B)(4). A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2025 AFTER OBSERVING WHAT THEY DESCRIBED AS DISCREPANT NEGATIVE D (RH1) ANTIGEN TYPING RESULTS WITH ONE CORD SAMPLE FROM A NEWBORN USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT: 112124037-22 AND MTS DILUENT 2 PLUS LOT: MDP246 IN COMBINATION WITH THEIR ORTHO VISION ID-MTS GEL CARD ANALYZER 50002946 (SOFTWARE VERSION 5.16.0). COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), LABORATORY TECHNOLOGIST. EVENTS DATES: 21 AND 23 APRIL 2025 PATIENT INFORMATION: NEWBORN SAMPLE ID: (B)(6) (ENCRYPTED 57-49-83-1F-12-CA-04-C3-50-8E-F0-C6-A2-91-FD-8F-17-F0-EE65-20-7B-31-64-B2-F4-CE-3C-3B-6D-1E-36) EXPECTED TO BE B D (RH1) POSITIVE REAGENT: MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD (PRODUCT CODE: MTS080515; LOT: 112124037-22 EXPIRY DATE 15 OCTOBER 2025; MANUFACTURE DATE 15 JANUARY 2025) MTS DILUENT 2 PLUS (PRODUCT CODE: MTS9330; LOT: MDP246; EXPIRY DATE 12 SEPTEMBER 2025; MANUFACTURE DATE 12 SEPTEMBER 2024) THE CUSTOMER REPORTED THAT ON (B)(6) 2025 AT 17:54, THEY HAD TESTED SEVERAL TIMES THE ABOVE SAMPLE (ID: (B)(6) FROM THIS NEWBORN FOR D (RH1) ANTIGEN TYPING USING MTS A/B/D MONOCLONAL AND REVERSE GROU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22103459 ↗
• MalfunctionJan 9, 2025False Negative Result; False Negative Result

  CMS (B)(4), WINDCHILL RA608629 ON (B)(6) 2024, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT A FALSE NEGATIVE RESULT OF THE ANTI-D COLUMN DURING A/B/D AND REVERSE GROUP TESTING FOR ONE PATIENT SAMPLE ON THEIR ORTHO WORKSTATION ID-MTS (SERIAL NUMBER: (B)(6) IN CONJUNCTION WITH MTS ABD MONOCLONAL AND REVERSE GEL CARD LOT 061424037-10. COMPLAINANT: (B)(6); MEDICAL TECHNOLOGIST; (B)(6), CUSTOMER (B)(6); (B)(6) HEALTHCARE; (B)(6)DATE OF EVENT: 11 DECEMBER 2024; REPORTED TO GTSC (B)(6) 2024 REAGENTS: MTS ABD MONOCLONAL AND REVERSE CARD (PRODUCT CODE MTS080515; LOT 061424037-10 (EXPIRY27MAR2025, MANUFACTURED 27JUN2024)) MTS ABD/ABD CARD (PRODUCT CODE MTS50811115; LOT 051024053-01; EXPIRY11FEB2025, MANUFACTURED 11MAY2024) NO ADDITIONAL DETAILS PROVIDED. PATIENT INFORMATION: NO HISTORY ON THIS PATIENT. THE CUSTOMER STATED THAT ON (B)(6)2024, A PATIENT SAMPLE WAS TESTED FOR ABD AND REVERSE GROUP UTILIZING THE ORTHO WORKSTATION (B)(4) IN CONJUNCTION WITH MTS ABD MONOCLONAL AND REVERSE GEL CARD LOT 061424037-10 AND THAT THEY OBTAINED A NEGATIVE REACTION FOR THE ANTI-D COLUMN. ON THE SAME DAY, IT IS UNDERSTOOD THAT THE SAME PATIENT SAMPLE WAS TESTED THREE OTHER TIM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112303 ↗
• MalfunctionNov 21, 2024False Positive Result; False Positive Result

  REPORT 1 OF 3 CMS (B)(4); WINDCHILL RA608052 THE CUSTOMER REPORTED TO GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) WHAT WAS DESCRIBED AS DISCREPANT POSITIVE D(RH1) TYPING RESULTS FOR A PATIENT SAMPLE USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 051424037-02 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (B)(6). COMPLAINANT/COMPLAINT REPORTER: (B)(6) - SENIOR TECHNICIAN DATE OF EVENT: 23 OCTOBER 2024 REPORTED ON: (B)(6) 2024 BY THE CUSTOMER BY EMAIL TO THE GTSC HELPDESK REAGENTS: ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 051424037-02, EXPIRY DATE 16FEB2025, MANUFACTURE DATE 16MAY2024 OTHER REAGENT: BENCH ANTI-D MANUFACTURED BY COMPETITOR, LOT# V260630, EXPIRY DATE 12JUL2025. PATIENT INFORMATION: PATIENT IS A MALE, 70 YEARS OLD. PATIENT DIAGNOSES: CHF, HYPERTENSION, DYSLIPIDEMIA, POST CABG, TOBACCO AND ALCOHOL DEPENDENCE, ABDOMINAL SWELLING AND LOWER EXTREMITY EDEMA. PATIENT WAS KNOWN TO BE A D(RH1) NEGATIVE (AT CUSTOMER'S LABORATORY ON (B)(6)2009). NO RECENT TRANSFUSIONS WERE KNOWN AT THEIR FACILITY OR NEIGHBORING FACILITIES. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED THAT ON (B)(6)2024, THEY HAD TESTED THREE TIMES THREE DIFFERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20744260 ↗
• MalfunctionNov 21, 2024False Positive Result; False Positive Result

  REPORT 3 OF 3 CMS (B)(4); WINDCHILL RA608052 THE CUSTOMER REPORTED TO GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) WHAT WAS DESCRIBED AS DISCREPANT POSITIVE D(RH1) TYPING RESULTS FOR A PATIENT SAMPLE USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 051424037-02 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (B)(6). COMPLAINANT/COMPLAINT REPORTER: (B)(6) - SENIOR TECHNICIAN DATE OF EVENT: 23 OCTOBER 2024 REPORTED ON: (B)(6) 2024 BY THE CUSTOMER BY EMAIL TO THE GTSC HELPDESK REAGENTS: ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 051424037-02, EXPIRY DATE 16FEB2025, MANUFACTURE DATE 16MAY2024 OTHER REAGENT: BENCH ANTI-D MANUFACTURED BY COMPETITOR, LOT V260630, EXPIRY DATE 12JUL2025. PATIENT INFORMATION: PATIENT IS A MALE, 70 YEARS OLD. PATIENT DIAGNOSES: CHF, HYPERTENSION, DYSLIPIDEMIA, POST CABG, TOBACCO AND ALCOHOL DEPENDENCE, ABDOMINAL SWELLING AND LOWER EXTREMITY EDEMA. PATIENT WAS KNOWN TO BE A D(RH1) NEGATIVE (AT CUSTOMER'S LABORATORY ON (B)(6)2009). NO RECENT TRANSFUSIONS WERE KNOWN AT THEIR FACILITY OR NEIGHBORING FACILITIES. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED THAT ON (B)(6)2024, THEY HAD TESTED THREE TIMES THREE DIFFEREN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20744210 ↗
• MalfunctionNov 20, 2024False Positive Result; False Positive Result

  REPORT 2 OF 3. CMS (B)(4); WINDCHILL (B)(4). THE CUSTOMER REPORTED TO (B)(4) WHAT WAS DESCRIBED AS DISCREPANT POSITIVE D(RH1) TYPING RESULTS FOR A PATIENT SAMPLE USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 051424037-02 IN CONJUNCTION WITH THEIR ORTHO VISION SWIFT ID-MTS ANALYZER (B)(6). COMPLAINANT/COMPLAINT REPORTER: MS. (B)(6) - SENIOR TECHNICIAN. DATE OF EVENT: 23 OCTOBER 2024, REPORTED ON: 23 OCTOBER 2024 BY THE CUSTOMER BY EMAIL TO THE (B)(4) HELPDESK REAGENTS: ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD LOT 051424037-02, EXPIRY DATE 16FEB2025, MANUFACTURE DATE 16MAY2024 OTHER REAGENT: BENCH ANTI-D MANUFACTURED BY COMPETITOR, LOT V260630, EXPIRY DATE 12JUL2025. PATIENT INFORMATION: PATIENT IS A MALE, 70 YEARS OLD. PATIENT DIAGNOSES: CHF, HYPERTENSION, DYSLIPIDEMIA, POST CABG, TOBACCO AND ALCOHOL DEPENDENCE, ABDOMINAL SWELLING AND LOWER EXTREMITY EDEMA. PATIENT WAS KNOWN TO BE A D(RH1) NEGATIVE (AT CUSTOMER'S LABORATORY ON (B)(6) 2009). NO RECENT TRANSFUSIONS WERE KNOWN AT THEIR FACILITY OR NEIGHBORING FACILITIES. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED THAT ON (B)(6) 2024, THEY HAD TESTED THREE TIMES THREE DIFFERENT SAMPLES FROM THIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737147 ↗
• MalfunctionSep 23, 2024False Negative Result; False Negative Result

  (B)(4), WINDCHILL RA607629. A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON 30 AUGUST 2024 TO REPORT DISCREPANT NEGATIVE ABO REVERSE TYPING RESULTS USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 041624037-03, MTS DILUENT 2 PLUS LOT MDP236 AND 0.8% AFFIRMAGEN LOTS 8A791 AND 8A804 FOR ONE PROFICIENCY SAMPLE OBTAINED WITH THEIR ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6), SOFTWARE VERSION 5.15.0. COMPLAINANT/COMPLAINT REPORTER NAME: MELISSA MIODRAGOVIC, LABORATORY SUPERVISOR. EVENTS DATES: 10 AND 30 AUGUST 2024. PROFICIENCY INFORMATION: A SUB-GROUP (NO FURTHER DETAIL PROVIDED) SAMPLE ID: (B)(6) REAGENTS: MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD (PRODUCT CODE MTS080515; LOT 041624037-03; EXPIRY DATE 18 JANUARY 2025) MTS DILUENT 2 PLUS (PRODUCT CODE MTS9330; LOT MDP236; EXPIRY DATE 01 AUGUST 2025) 0.8% AFFIRMAGEN (PRODUCT CODE 719201; LOT 8A791; EXPIRY DATE 20 AUGUST 2024) 0.8% AFFIRMAGEN (PRODUCT CODE 719201; LOT 8A804; EXPIRY DATE 17 SEPTEMBER 2024) THE CUSTOMER REPORTED THAT ON 10 AUGUST 2024, THEY HAD TESTED SAMPLE_AUT-07 FOR ABO FORWARD/REVERSE AND D(RH1) ANTIGEN USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 041624037-03, MTS DILUENT 2 PLUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278624 ↗
• MalfunctionSep 19, 2024False Positive Result; False Positive Result

  REPORT 2 OF 5 CMS (B)(4), WINDCHILL RA607409 COMPLAINT DESCRIPTION: ON (B)(6)2024, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE D(RH1) TYPING RESULTS FOR TWO PATIENT SAMPLES USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARDS (LOT INFORMATION NOT PROVIDED) IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER. COMPLAINANT/COMPLAINT REPORTER: (B)(6) ; LABORATORY MANAGER; (B)(6); : 1083829; (B)(6) HOSPITAL; (B)(6) DATE OF EVENTS: 02SEP2023, 23APR2024, 27JUN2024 AND 15AUG2024 REPORTED ON 23AUG2024. REAGENTS: ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD - LOTS REQUESTED AND NOT PROVIDED MANUAL TUBE METHOD ANTI-SERA - MANUFACTURER AND LOT INFORMATION REQUESTED AND NOT PROVIDED ORTHO VISION ID-MTS ANALYZER - SERIAL (B)(6) PATIENT INFORMATION: PATIENT ONE - PREGNANT FEMALE; ANTIBODY SCREEN NEGATIVE. TUBE ABORH ANTI-D AT IMMEDIATE SPIN IS NEGATIVE, WEAK D IS 2+ BY TUBE METHOD. NO DETAILS PROVIDED. HISTORY AT SISTER FACILITY (B)(6) - (B)(6) 2024, TESTED ON COMPETITOR PLATFORM, RESULTS: 1+ AND NEGATIVE FROM TWO DIFFERENT ANTI-D REAGENTS. RHD NEGATIVE REPORTED. RHOGAM ADMINISTERED (B)(6) 2024. PATIENT TWO -

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20254733 ↗
• MalfunctionSep 19, 2024False Positive Result; False Positive Result

  REPORT 3 OF 5 CMS 2647009, WINDCHILL (B)(6) COMPLAINT DESCRIPTION: ON 23AUG2024, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE D(RH1) TYPING RESULTS FOR TWO PATIENT SAMPLES USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARDS (LOT INFORMATION NOT PROVIDED) IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER. COMPLAINANT/COMPLAINT REPORTER: (B)(6) HOSPITAL; DATE OF EVENTS: (B)(6) 2023 AND (B)(6) 2024 REPORTED ON (B)(6) 2024. REAGENTS: ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD - LOTS REQUESTED AND NOT PROVIDED MANUAL TUBE METHOD ANTI-SERA - MANUFACTURER AND LOT INFORMATION REQUESTED AND NOT PROVIDED ORTHO VISION ID-MTS ANALYZER - SERIAL (B)(6) PATIENT INFORMATION: PATIENT ONE - PREGNANT FEMALE; ANTIBODY SCREEN NEGATIVE. TUBE ABORH ANTI-D AT IMMEDIATE SPIN IS NEGATIVE, WEAK D IS 2+ BY TUBE METHOD. NO DETAILS PROVIDED. HISTORY AT SISTER FACILITY (B)(6) - (B)(6) 2024, TESTED ON COMPETITOR PLATFORM, RESULTS: 1+ AND NEGATIVE FROM TWO DIFFERENT ANTI-D REAGENTS. RHD NEGATIVE REPORTED. RHOGAM ADMINISTERED (B)(6) 2024. PATIENT TWO - PREGNANT FEMALE; UNKNOWN RHD HISTORY. NO ADDITIONAL DETAILS PROVIDED. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20254631 ↗
• MalfunctionSep 19, 2024False Positive Result; False Positive Result

  REPORT 5 OF 5 CMS (B)(4), WINDCHILL (B)(4). COMPLAINT DESCRIPTION: ON (B)(6) 2024, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE D(RH1) TYPING RESULTS FOR TWO PATIENT SAMPLES USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARDS (LOT INFORMATION NOT PROVIDED) IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER. COMPLAINANT/COMPLAINT REPORTER: (B)(6); LABORATORY MANAGER; (B)(6) ; : 1083829; (B)(6) HOSPITAL; (B)(6) DATE OF EVENTS: 02SEP2023, 23APR2024, 27JUN2024 AND 15AUG2024 REPORTED ON (B)(6) 2024. REAGENTS: ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD - LOTS REQUESTED AND NOT PROVIDED MANUAL TUBE METHOD ANTI-SERA - MANUFACTURER AND LOT INFORMATION REQUESTED AND NOT PROVIDED ORTHO VISION ID-MTS ANALYZER - SERIAL (B)(60. PATIENT INFORMATION: PATIENT ONE - PREGNANT FEMALE; ANTIBODY SCREEN NEGATIVE. TUBE ABORH ANTI-D AT IMMEDIATE SPIN IS NEGATIVE, WEAK D IS 2+ BY TUBE METHOD. NO DETAILS PROVIDED. HISTORY AT SISTER FACILITY (B)(6) - ON (B)(6) 2024, TESTED ON COMPETITOR PLATFORM, RESULTS: 1+ AND NEGATIVE FROM TWO DIFFERENT ANTI-D REAGENTS. RHD NEGATIVE REPORTED. RHOGAM ADMINISTERED (B)(6) 2024. PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20254480 ↗
• MalfunctionSep 18, 2024False Positive Result; False Positive Result

  REPORT 4 OF 5 CMS (B)(4), WINDCHILL (B)(4) COMPLAINT DESCRIPTION: ON (B)(6) 2024, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE D(RH1) TYPING RESULTS FOR TWO PATIENT SAMPLES USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARDS (LOT INFORMATION NOT PROVIDED) IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER. COMPLAINANT/COMPLAINT REPORTER: (B)(6), DATE OF EVENTS: 02SEP2023, 23APR2024, 27JUN2024 AND 15AUG2024 REPORTED ON 23AUG2024. REAGENTS: ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD - LOTS REQUESTED AND NOT PROVIDED MANUAL TUBE METHOD ANTI-SERA - MANUFACTURER AND LOT INFORMATION REQUESTED AND NOT PROVIDED ORTHO VISION ID-MTS ANALYZER - SERIAL (B)(6) PATIENT INFORMATION: PATIENT ONE - PREGNANT FEMALE; ANTIBODY SCREEN NEGATIVE. TUBE ABORH ANTI-D AT IMMEDIATE SPIN IS NEGATIVE, WEAK D IS 2+ BY TUBE METHOD. NO DETAILS PROVIDED. HISTORY AT SISTER FACILITY (B)(6) - (B)(6)2024, TESTED ON COMPETITOR PLATFORM, RESULTS: 1+ AND NEGATIVE FROM TWO DIFFERENT ANTI-D REAGENTS. RHD NEGATIVE REPORTED. RHOGAM ADMINISTERED (B)(6) 2024. PATIENT TWO - PREGNANT FEMALE; UNKNOWN RHD HISTORY. NO ADDITIONAL DETAILS PROVID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246632 ↗
• MalfunctionSep 18, 2024False Positive Result; False Positive Result

  REPORT 1 OF 5 (B)(4), WINDCHILL RA607409 COMPLAINT DESCRIPTION: ON (B)(6) 2024, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT POSITIVE D(RH1) TYPING RESULTS FOR TWO PATIENT SAMPLES USING ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARDS (LOT INFORMATION NOT PROVIDED) IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER. COMPLAINANT/COMPLAINT REPORTER: (B)(6); LABORATORY MANAGER; (B)(6); (B)(6); HOSPITAL; (B)(6) DATE OF EVENTS: 02SEP2023, 23APR2024, 27JUN2024 AND 15AUG2024 REPORTED ON 23AUG2024. REAGENTS: ORTHO MTS A/B/D MONOCLONAL & REVERSE GROUPING CARD - LOTS REQUESTED AND NOT PROVIDED MANUAL TUBE METHOD ANTI-SERA - MANUFACTURER AND LOT INFORMATION REQUESTED AND NOT PROVIDED ORTHO VISION ID-MTS ANALYZER - SERIAL (B)(6) PATIENT INFORMATION: PATIENT ONE - PREGNANT FEMALE; ANTIBODY SCREEN NEGATIVE. TUBE ABORH ANTI-D AT IMMEDIATE SPIN IS NEGATIVE, WEAK D IS 2+ BY TUBE METHOD. NO DETAILS PROVIDED. HISTORY AT SISTER FACILITY (B)(6) - ON (B)(6) 2024, TESTED ON COMPETITOR PLATFORM, RESULTS: 1+ AND NEGATIVE FROM TWO DIFFERENT ANTI-D REAGENTS. RHD NEGATIVE REPORTED. RHOGAM ADMINISTERED (B)(6) 2024. PATIENT TWO - PREGNANT FE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245814 ↗
• MalfunctionSep 13, 2024False Negative Result; False Negative Result

  REPORT 1 OF 2 CMS 2648200 AND 2648215, WINDCHILL RA607373 ON 15AUG2024, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS FALSE NEGATIVE RESULTS OF THE ANTI-A COLUMN WHEN PERFORMING ABORH TESTING ON TWO SAMPLES FROM ONE PATIENT USING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOTS 051424037-03 AND 051424037-11 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER. CUSTOMER NAME: (B)(6); EVENT DATES: 07AUG2024 AND 13AUG2024, REPORTED TO GTSC 15AUG2024. CORRECTED REPORT SENT TO CLINICIAN 13AUG2024 AUTOMATED TESTING REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 051424037-03(EXPIRY 17FEB2025) MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 051424037-11(EXPIRY 20FEB2025) 0.8% AFFIRMAGEN LOT 8A802(EXPIRY 03SEP2024) MTS DILUENT 2 PLUS LOT INFORMATION NOT PROVIDED MANUAL TESTING WITH ORTHO REAGENTS: ANTI-A LOT BAA634A (EXPIRY 05MAR2026) ANTI-B LOT BBB826A (EXPIRY 09JAN2026) ANTI-D LOT DB348A1 (EXPIRY 14MAR2026) ALBUMIN LOT U2106 (EXPIRY 05FEB2026) 3% AFFIRMAGEN A1 AND B CELLS LOT A822 (EXPIRY 20AUG2024) TESTING METHODS: AUTOMATED GEL: ORTHO VISION ID-MTS SERIAL (B)(6); (INSTALLED 24JUL2020) MANUAL TUBE: REAGENTS PROVIDED ABOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20217052 ↗
• MalfunctionSep 13, 2024False Negative Result; False Negative Result

  REPORT 2 OF 2 CMS (B)(4); WINDCHILL RA607373 ON 15AUG2024, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS FALSE NEGATIVE RESULTS OF THE ANTI-A COLUMN WHEN PERFORMING ABORH TESTING ON TWO SAMPLES FROM ONE PATIENT USING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOTS 051424037-03 AND 051424037-11 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER. CUSTOMER NAME: (B)(6), MEDICAL TECHNOLOGIST (B)(6) CUSTOMER (B)(6); (B)(6) HEALTH CARE (B)(6), EVENT DATES: 07AUG2024 AND 13AUG2024, REPORTED TO (B)(6) 2024. CORRECTED REPORT SENT TO CLINICIAN (B)(6) 2024 AUTOMATED TESTING REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 051424037-03(EXPIRY 17FEB2025) MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 051424037-11(EXPIRY 20FEB2025) 0.8% AFFIRMAGEN LOT 8A802(EXPIRY 03SEP2024) MTS DILUENT 2 PLUS LOT INFORMATION NOT PROVIDED MANUAL TESTING WITH ORTHO REAGENTS: ANTI-A LOT BAA634A (EXPIRY 05MAR2026) ANTI-B LOT BBB826A (EXPIRY 09JAN2026) ANTI-D LOT DB348A1 (EXPIRY 14MAR2026) ALBUMIN LOT U2106 (EXPIRY 05FEB2026) 3% AFFIRMAGEN A1 AND B CELLS LOT A822 (EXPIRY 20AUG2024) TESTING METHODS: AUTOMATED GEL: ORTHO VISION ID-MTS SERIAL (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20215679 ↗
• MalfunctionJul 15, 2024False Positive Result; False Positive Result

  (B)(4) WINDCHILL (B)(4) ON 17JUN2024, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS FALSE POSITIVE RESULTS OF ANTI-B(ABO2), ANTI-D(RH1) AND CONTROL COLUMNS WHEN PERFORMING ABORH TESTING ON ONE NEWBORN PATIENT AND TWO QUALITY CONTROL (QC) SAMPLES USING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 012624037-22 (EXPIRY 15NOV2024) IN MANUAL GEL METHOD WITH THEIR ORTHO WORKSTATION (SERIAL (B)(6)). CUSTOMER NAME: (B)(6) HOSPITAL. EVENTS DATE: 17JUN2024, REPORTED SAME DAY. REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 012624037-22 (EXPIRY 15NOV2024, MANUFACTURED 15FEB2024) MTS DILUENT 2 PLUS LOT MDP237 (EXPIRY 29JAN2025) QUALITY CONTROL MATERIAL - ORTHO CONFIDENCE SYSTEM LOT CNF348 (EXPIRY 25JUN2024) TESTING METHODS: MANUAL GEL: ORTHO WORKSTATION SERIAL (B)(6) (INSTALLED (B)(6) 2019) AUTOMATED: ORTHO VISION ID-MTS SERIAL (B)(6) (INSTALLED (B)(6) 2017) MANUAL TUBE: NO DETAILS PROVIDED. SAMPLE INFORMATION: SAMPLE 1 - PATIENT (A POSITIVE NEWBORN) ANTI-B COLUMN-FALSE POSITIVE (2+) REPEATED IN TUBE (ANTI-B NEGATIVE) AND IN MANUAL GEL (ANTI-B COLUMN NEGATIVE). SAMPLE 2 - AB NEGATIVE QC MATERIAL ORTHO CONFIDENCE CELL 1 ANTI-D C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19739651 ↗
• MalfunctionMay 21, 2024False Positive Result; False Positive Result

  CMS (B)(4), WINDCHILL RA606105 ON 24APR2024, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS DISCREPANT FALSE POSITIVE RESULTS OF THE RHD TYPING FOR ONE PATIENT USING MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 110923037-12 (EXPIRY 11SEP2024) IN COMBINATION WITH THEIR ORTHO VISION ID-MTS ANALYZER (SERIAL (B)(6) ). CUSTOMER NAME: (B)(6), MEDICAL TECHNOLOGIST (B)(6) CUSTOMER # (B)(6), (B)(6) EVENT DATES: 17MAY2023 AND 27FEB2024, REPORTED 24APR2024. REAGENTS: MTS ABD MONOCLONAL AND REVERSE CARD LOT REQUESTED AND NOT PROVIDED - FOR 17MAY2023 TESTING. MTS ABD MONOCLONAL AND REVERSE CARD LOT 119023037-12 (EXPIRY: 11SEP2024, MANUFACTURE: 19DEC2023) - UTILIZED FOR 27FEB2024 TESTING. COMPETITOR PRODUCT USED FOR TUBE ABORH TESTING AND WEAK D TESTING. PATIENT INFORMATION: SAMPLE ID: FROM TESTING ON (B)(6), (ENCRYPTION: D3-DC-30-90-A4-F1-9E-0E-95-E8-40-56-E1-7F-41-A7-FF-D1-40-44-1D-DE-D3-41-2F-37-BB-40-F5-9F-5D-B4) PRENATAL PATIENT COMPLAINT DESCRIPTION: CUSTOMER REPORTED THAT ON (B)(6) 2024 A PRENATAL PATIENT SAMPLE WAS TESTED FOR ABORH ON THE ORTHO VISION ANALYZER AND A MIXED FIELD (MF) FLAG WAS POSTED IN THE ANTI-D COLUMN. THE CUSTOMER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19357556 ↗