SURGISCREEN 6902316Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10758750007660), received between Dec 9, 2022 and Apr 17, 2026 — classified as 2 deaths, 25 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (26 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026False Negative Result

  (B)(6) ON 24MAR2026, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS FOR ANTIBODY SCREEN AND ANTIBODY IDENTIFICATION FOR ONE PATIENT SAMPLE USING 0.8% SURGISCREEN LOT VSS727 AND 0.8% RESOLVE PANEL A LOT VRA506 WITH ORTHO MTS ANTI-IGG GEL CARD LOT 110825001-12 ON THEIR ORTHO VISION SWIFT ID-MTS (50004113). COMPLAINANT: (B)(6) MEDICAL TECHNOLOGIST; (B)(6); (B)(6) MEDICAL CENTER (B)(6) USA. DATE OF EVENT: (B)(6) 2026, REPORTED ON 24MAR2026 REAGENTS: 0.8% SURGISCREEN LOT VSS727, EXPIRATION: 14APR2026, MANUFACTURE: 10FEB2026 0.8% RESOLVE PANEL A LOT VRA506, EXPIRATION: 14APR2026, MANUFACTURE: 10FEB2026 MTS ANTI-IGG GEL CARD LOT 110825001-12, EXPIRATION: 04SEP2026, MANUFACTURE: 04DEC2025 OTHER REAGENTS: 3% SURGISCREEN LOT 3SS792, EXPIRATION: 31MAR2026 INSTRUMENT: ORTHO VISION SWIFT ID-MTS, SN (B)(6); SW VERSION: 5.17.0 PATIENT INFORMATION: SAMPLE ID: (B)(6); ENCRYPTED SAMPLE ID: (B)(6). PATIENT HAD PREVIOUSLY IDENTIFIED ANTI-M(MNS1) ANTIBODY. PATIENT WAS NOT TRANSFUSED WITH ANY UNITS POSITIVE FOR M(MNS1) ANTIGEN. NO FURTHER INFORMATION PROVIDED. THE CUSTOMER REPORTED THAT ON (B)(6) 2026, A SAMPLE F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916810 ↗
• MalfunctionApr 17, 2026False Negative Result

  REPORT 1 OF 2 (B)(4) / RA614154 ON 27MAR2026, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS FOR ANTIBODY SCREEN FOR ONE PATIENT USING 0.8% SURGISCREEN LOT: VSS728 WITH ORTHO MTS ANTI-IGG GEL CARD LOT: 110825001-06 ON THEIR ORTHO VISION SWIFT ID-MTS (B)(6). COMPLAINANT: (B)(6), MEDICAL TECHNOLOGIST; (B)(6) CUSTOMER (B)(6) (B)(6) HOSPITAL (B)(6) USA DATE OF EVENT: 26MAR2026 AND 29MAR2026, REPORTED ON 27MAR2026 REAGENTS: 0.8% SURGISCREEN LOT: VSS728, EXPIRATION: 14APR2026, MANUFACTURE: 10FEB2026 MTS ANTI-IGG GEL CARD LOT: 110825001-06, EXPIRATION: 24AUG2026, MANUFACTURE: 24NOV2025 OTHER REAGENTS: 0.8% RESOLVE PANEL A LOT: VRA506, EXPIRATION: 14APR2026 INSTRUMENT: ORTHO VISION SWIFT ID-MTS S/N: (B)(6); SW VERSION 5.16.0 PATIENT INFORMATION: PATIENT HAS A HISTORY OF AN ANTI-JKA (JK1) ANTIBODY. SAMPLE 1 ID: (B)(6); ENCRYPTED ID- 80-FE-55-7D-8F-8B-E6-88-26-F1-EA-8C-6A-39-F9-8F-A9-A4-3F-67-F9-49-6D-BC-C8-0F-5D-4D-A6-B3-02-DD SAMPLE 2 ID: (B)(6); ENCRYPTED ID- 62-EF-E0-B7-F6-C9-A3-C2-62-0A-BF-09-50-10-3B-0B-E2-1C-58-00-43-44-27-76-11-BC-9D-C1-C2-DC-7B-8D THE CUSTOMER REPORTED THAT ON (B)(6) 2026, SA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910283 ↗
• MalfunctionApr 17, 2026False Negative Result

  REPORT 2 OF 2. (B)(4). ON 27MAR2026, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS FOR ANTIBODY SCREEN FOR ONE PATIENT USING 0.8% SURGISCREEN LOT VSS728 WITH ORTHO MTS ANTI-IGG GEL CARD LOT 110825001-06 ON THEIR ORTHO VISION SWIFT ID-MTS (B)(6). (B)(6). DATE OF EVENT: (B)(6) 2026 AND (B)(6) 2026, REPORTED ON 27MAR2026. REAGENTS: 0.8% SURGISCREEN LOT VSS728, EXPIRATION: 14APR2026, MANUFACTURE: 10FEB2026 MTS ANTI-IGG GEL CARD LOT 110825001-06, EXPIRATION: 24AUG2026, MANUFACTURE: 24NOV2025. OTHER REAGENTS: 0.8% RESOLVE PANEL A LOT VRA506, EXPIRATION: 14APR2026 INSTRUMENT: ORTHO VISION SWIFT ID-MTS S/N (B)(6); SW VERSION 5.16.0 PATIENT INFORMATION: PATIENT HAS A HISTORY OF AN ANTI-JKA(JK1) ANTIBODY. SAMPLE 1 ID- (B)(6); ENCRYPTED ID- (B)(6). SAMPLE 2 ID- (B)(6); ENCRYPTED ID- (B)(6). THE CUSTOMER REPORTED THAT ON (B)(6) 2026, SAMPLE 1 FROM THE PATIENT WAS TESTED FOR ANTIBODY SCREEN USING 0.8% SURGISCREEN LOT VSS728 WITH MTS ANTI-IGG GEL CARD LOT 110825001-06 ON THE ORTHO VISION SWIFT ID-MTS ANALYZER (B)(6) AND A NEGATIVE REACTION WAS OBTAINED WITH ALL THREE SCREENING CELLS. THE CUSTOMER REPORTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910280 ↗
• MalfunctionJan 30, 2026False Negative Result

  (B)(4) ON (B)(6) 2026, A CUSTOMER CONTACTED THE ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) AFTER OBSERVING WHAT WAS DESCRIBED AS DISCORDANT NEGATIVE REACTIONS FOR ANTIBODY SCREEN AND ANTIBODY IDENTIFICATION IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT SAMPLE USING 0.8% SURGISCREEN LOT VSS701 AND 0.8% RESOLVE PANEL A LOT VRA499 WITH ORTHO MTS ANTI-IGG GEL CARD LOT 072225001-14 ON THEIR ORTHO WORKSTATION ID-MTS (B)(4). COMPLAINANT: (B)(6) USA DATE OF EVENT: 01JAN2026 AND 04JAN2026, REPORTED ON (B)(6) 2026 REAGENTS: 0.8% SURGISCREEN LOT VSS701, EXPIRATION: 06JAN2026, MANUFACTURE: 04NOV2025 0.8% RESOLVE PANEL A LOT VRA499, EXPIRATION: 06JAN2026, MANUFACTURE: 04NOV2025 MTS ANTI-IGG GEL CARD LOT 062525001-29, EXPIRATION: 07JUL2026, MANUFACTURE: 07OCT2025 INSTRUMENTS: ORTHO WORKSTATION ID-MTS (B)(4) PATIENT INFORMATION: MALE, PREVIOUS NEGATIVE ANTIBODY SCREEN ON (B)(6) 2025 PERFORMED AT ANOTHER FACILITY. PREVIOUSLY TRANSFUSED WITH 4 DONOR RED BLOOD CELL UNITS -FROM (B)(6) 2025. RECENTLY TRANSFUSED WITH 2 DONOR RED BLOOD CELL UNITS ON (B)(6) 2026. NEWLY IDENTIFIED ANTI-JKA(JK1) ANTIBODY. THE CUSTOMER REPORTED THAT ON (B)(6) 2026, A SAMPLE FROM THE PATIENT WAS TESTED USING A COMPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221313 ↗
• MalfunctionDec 18, 2025False Negative Result; False Negative Result

  REPORT 2 OF 2 CMS (B)(4) A CUSTOMER CONTACTED (B)(6) ON (B)(6) 2025 TO REPORT WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE REACTION IN ANTIBODY SCREEN IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR TWO SAMPLES FROM ONE PATIENT, USING 0.8% SURGISCREEN LOT VSS689 AND ORTHO MTS ANTI-IGG GEL CARD LOT 071025001-04 ON THEIR ORTHO VISION SWIFT ID-MTS ANALYZERS (B)(4). COMPLAINANT/COMPLAINT REPORTER: (B)(6)- MEDICAL TECHNOLOGIST; (B)(6) USA DATE OF EVENTS: 13NOV2025 AND 19NOV2025, REPORTED ON 20NOV2025 INSTRUMENTS: ORTHO VISION SWIFT ID-MTS - (B)(4), SW VERSION 5.16.0 ORTHO VISION SWIFT ID-MTS - (B)(4), SW VERSION 5.16.0 REAGENTS: 0.8% SURGISCREEN LOT VSS689, EXPIRATION: 25NOV2025, MANUFACTURE: 23SEP2025 MTS ANTI-IGG GEL CARD LOT 071025001-04, EXPIRATION: 01MAY2026, MANUFACTURE: 01AUG2025 OTHER REAGENTS: A COMPETITOR'S ANTIBODY SCREEN AND ANTIBODY IDENTIFICATION PANEL RED CELL REAGENTS PATIENT INFORMATION: THE PATIENT HAD A PRIOR ANTIBODY SCREEN PERFORMED ON (B)(6) 2025 RESULTED AS POSITIVE AND A SUBSEQUENT ANTIBODY ID IDENTIFIED A NON-SPECIFIC ANTIBODY. NO HISTORY OF TRANSFUSIONS; NO ADDITIONAL INFORMATION WAS PROVIDED. SAMPLE A- DRAWN (B)(6) 2025, ID (B)(6), ENCRYPTED ID (B)(4) SAMPLE B- DRAWN (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23842533 ↗
• MalfunctionDec 18, 2025False Negative Result; False Negative Result

  REPORT 1 OF 2 CMS (B)(6) A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2025 TO REPORT WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE REACTION IN ANTIBODY SCREEN IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR TWO SAMPLES FROM ONE PATIENT, USING 0.8% SURGISCREEN LOT: VSS689 AND ORTHO MTS ANTI-IGG GEL CARD LOT: 071025001-04 ON THEIR ORTHO VISION SWIFT ID-MTS ANALYZERS 50004008 AND 50004007. COMPLAINANT/COMPLAINT REPORTER: (B)(6)- MEDICAL TECHNOLOGIST; (B)(6) CUSTOMER (B)(6) USA DATE OF EVENTS: 13NOV2025 AND 19NOV2025, REPORTED ON 20NOV2025 INSTRUMENTS: ORTHO VISION SWIFT ID-MTS - 50004008, SW VERSION 5.16.0 ORTHO VISION SWIFT ID-MTS - 50004007, SW VERSION 5.16.0 REAGENTS: 0.8% SURGISCREEN LOT: VSS689, EXPIRATION: 25NOV2025, MANUFACTURE: 23SEP2025 MTS ANTI-IGG GEL CARD LOT: 071025001-04, EXPIRATION: 01MAY2026, MANUFACTURE: 01AUG2025 OTHER REAGENTS: A COMPETITOR'S ANTIBODY SCREEN AND ANTIBODY IDENTIFICATION PANEL RED CELL REAGENTS PATIENT INFORMATION: THE PATIENT HAD A PRIOR ANTIBODY SCREEN PERFORMED ON (B)(6) 2025 RESULTED AS POSITIVE AND A SUBSEQUENT ANTIBODY ID IDENTIFIED A NON-SPECIFIC ANTIBODY. NO HISTORY OF TRANSFUSIONS; NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23841992 ↗
• MalfunctionDec 15, 2025False Negative Result; False Negative Result

  (B)(4) / RA612822 A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2025 TO REPORT WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE REACTION IN ANTIBODY SCREEN IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT SAMPLE USING 0.8% SURGISCREEN LOT VSS690 AND ORTHO MTS ANTI-IGG GEL CARD LOT 052025001-01 ON THEIR ORTHO VISION ID-MTS ANALYZER (B)(6). COMPLAINANT/COMPLAINT REPORTER: (B)(6)- MEDICAL TECHNOLOGIST; (B)(6) CUSTOMER (B)(6) DATE OF EVENT: 07NOV2025, REPORTED ON 18NOV2025 INSTRUMENT: ORTHO VISION ID-MTS - (B)(6), SW VERSION 5.16.0 REAGENTS: 0.8% SURGISCREEN LOT VSS690, EXPIRATION: 25NOV2025, MANUFACTURE: 23SEP2025 MTS ANTI-IGG GEL CARD LOT 052025001-01, EXPIRATION: 09MAR2026, MANUFACTURE: 09JUN2025 OTHER REAGENTS: MTS ANTI-IGG GEL CARD LOT 062525001-26, EXPIRATION: 17JUN2026 MTS BUFFERED GEL CARD LOT 033125004-01, EXPIRATION: 07JAN2026 0.8% RESOLVE PANEL B LOT VRB343, EXPIRATION: 25NOV2025 0.8% RESOLVE PANEL C LOT VRC342, EXPIRATION: 25NOV2025 PATIENT INFORMATION: NO PRIOR HISTORY AVAILABLE. SAMPLE A- COLLECTED ON (B)(6) 2025 SAMPLE B- COLLECTED ON (B)(6) 2025 THE CUSTOMER REPORTED THAT ON (B)(6) 2025, A SAMPLE FROM THE PATIENT (SAMPLE A) WAS TESTED FOR AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802066 ↗
• MalfunctionOct 29, 2025False Negative Result; False Negative Result

  (B)(4) ON (B)(6) 2025, A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) TO REPORT WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE ANTIBODY SCREENING RESULT IN THE INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT USING REAGENT RED BLOOD CELLS, 0.8% SURGISCREEN LOT VSS683 AND MTS ANTI-IGG GEL CARD LOT 042825001-06 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (B)(6). COMPLAINANT: (B)(6), MEDICAL TECHNOLOGIST: (B)(6), DATE OF EVENT: 03OCT2025, REPORTED ON 06OCT2025, REAGENT(S): 0.8% SURGISCREEN LOT VSS683, EXPIRATION DATE: 28OCT2025, DATE OF MANUFACTURE: 26AUG2025. MTS ANTI-IGG GEL CARD LOT 042825001-06, EXPIRATION DATE: 03MAR2026, DATE OF MANUFACTURE: 03JUN2025. ADDITIONAL REAGENTS: 0.8% RESOLVE PANEL A LOT VRA494, EXPIRATION DATE: 28OCT2025, DATE OF MANUFACTURE: 26AUG2025. MTS ABD MONOCLONAL AND REVERSE GROUPING GEL CARD LOT 041625037-18, EXPIRATION DATE: 28FEB2026, DATE OF MANUFACTURE: 28MAY2025. 0.8% AFFIRMAGEN LOT 8A996, EXPIRATION DATE: 14OCT2025, DATE OF MANUFACTURE: 29JUL2025. ANALYZER: ORTHO VISION ID-MTS, (B)(6), INSTALL DATE: (B)(6) 2019, SW VERSION 5.16.0 PATIENT INFORMATION: SAMPLE ID: (B)(6); ENCRYPTED SAMPLE ID: (B)(6), PREVIOUS ANTIBODY HISTORY N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412118 ↗
• MalfunctionJul 2, 2025False Negative Result; False Negative Result

  (B)(4) / (B)(6) ON (B)(6) 2025, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS A DISCREPANT FALSE NEGATIVE ANTIBODY SCREEN RESULT FOR ONE PATIENT SAMPLE USED FOR COMPETENCY TESTING IN MANUAL GEL METHOD USING 0.8% SURGISCREEN LOT VSS653, EXPIRY 08JUL2025, IN CONJUNCTION WITH MTS ANTI-IGG CARD LOT 021125001-04, EXPIRY 06DEC2025. COMPLAINANT: (B)(6), DATE OF EVENT: 13JUN2025, DATE REPORTED: 13JUN2025 REAGENTS: 0.8% SURGISCREEN LOT VSS653 EXPIRY: 08JUL2025, MANUFACTURED: 06MAY2025 MTS ANTI-IGG GEL CARD LOT 021125001-04 EXPIRY: 06DEC2025, MANUFACTURED: 06MAR2025 INSTRUMENT: ORTHO WORKSTATION ID-MTS, 51002606 ORTHO VISION ID-MTS ANALYZER, 50004450 PATIENT INFORMATION: SAMPLE ID (ENCRYPTED): (B)(6). KNOWN HISTORY OF ANTI-FYB(FY2). NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED ON (B)(6) 2025 THEY SELECTED A SAMPLE FROM A PATIENT WITH A HISTORY OF ANTIFYB(FY2) TO BE USED FOR BI-ANNUAL SIDE-BY-SIDE METHOD COMPARISON PROFICIENCY TESTING ON THE ORTHO VISION ID-MTS ANALYZER VS. ORTHO WORKSTATION. THE PATIENT SAMPLE WAS THEN TESTED FOR ANTIBODY SCREEN ON THE ORTHO VISION ID-MTS ANALYZER (B)(4), USING 0.8% SURGISCREEN LOT VSS653

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384955 ↗
• MalfunctionJul 2, 2025False Negative Result; False Negative Result

  CMS 100244811/100244826, RA611230 A CUSTOMER CONTACTED ORTHO GLOBAL TECHNICAL SUPPORT CENTRE (GTSC) ON 12 JUNE 2025 AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT NEGATIVE ANTIBODY SCREENING RESULTS FOR A PATIENT USING 0.8% SURGISCREEN LOT VSS655 AND ORTHO ID-MTS ANTI-IGG GEL CARD LOT 101824001-05 AND IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYSER (50003528) AND ORTHO ID-MTS WORKSTATION (51000948). COMPLAINANT/COMPLAINT REPORTER: DAOPING ZHANG - LABORATORY SUPERVISOR DATE OF EVENTS: 12 JUNE 2025 REPORTED ON: 12 JUNE 2025 BY DAOPING ZHANG TO ORTHO GTSC REAGENTS: 0.8% SURGISCREEN LOT VSS655 EXPIRY DATE 08 JULY 2025 MANUFACTURE DATE 06 MAY 2025 0.8% SURGISCREEN LOT VSS657 EXPIRY DATE 08 JULY 2025 MANUFACTURE DATE 06 MAY 2025 ORTHO ID-MTS ANTI-IGG GEL CARD LOT 101824001-05 EXPIRY DATE 01 AUGUST 2025 MANUFACTURE DATE 01 NOVEMBER 2024 PATIENT INFORMATION: KNOWN ANTI-E(RH3) ANTIBODY THE CUSTOMER REPORTED THAT ON 12 JUNE 2025, THEY HAD TESTED A PATIENT SAMPLE FOR ANTIBODY SCREENING USING 0.8% SURGISCREEN LOT VSS655 AND ORTHO ID-MTS ANTI-IGG GEL CARD LOT 101824001-05 AND IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (50003528) AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384945 ↗
• MalfunctionJul 2, 2025False Negative Result; False Negative Result

  CMS (B)(4) RA611221 ON (B)(6) 2025, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS A DISCREPANT FALSE NEGATIVE ANTIBODY SCREEN RESULT FOR ONE PATIENT SAMPLE IN MANUAL GEL METHOD USING 0.8% SURGISCREEN LOT VSS655, EXPIRY 08JUL2025, IN CONJUNCTION WITH MTS ANTI-IGG CARD LOT 021125001-08, EXPIRY 12DEC2025. COMPLAINANT: (B)(6), LABORATORY SUPERVISOR (B)(6); (B)(6) DATE OF EVENT: 12JUN2025, DATE REPORTED: 12JUN2025 REAGENTS: 0.8% SURGISCREEN LOT VSS655 EXPIRY: 08JUL2025, MANUFACTURED: 06MAY2025 LOT VSS658 EXPIRY: 22JUL2025, MANUFACTURED: 20MAY2025 MTS ANTI-IGG GEL CARD LOT 021125001-08 EXPIRY: 12DEC2025, MANUFACTURED: 12MAR2025 0.8% RESOLVE PANEL B LOT VRB338 EXPIRY: 08JUL2025, MANUFACTURED: 06MAY2025 PATIENT INFORMATION: PREVIOUS HISTORY OF ANTI-E(RH3), NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED ON (B)(6) 2025 THEY SELECTED A SAMPLE FROM A PATIENT WITH A HISTORY OF ANTIE(RH3) TO BE USED FOR COMPETENCY TESTING USING MANUAL GEL METHOD. THE CUSTOMER TESTED THE PATIENT SAMPLE UTILIZING 0.8% SURGISCREEN LOT VSS655 AND MTS ANTI-IGG GEL CARD LOT 021125001-08 AND OBTAINED NEGATIVE REACTIONS WITH THE THREE SCREENING CELLS OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384943 ↗
• MalfunctionApr 3, 2025False Negative Result; False Negative Result

  CMS (B)(4), WINDCHILL RA609454 A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2025 AFTER OBSERVING WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE ANTIBODY SCREENING RESULT IN INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% SURGISCREEN LOT VSS628 AND ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD 111224001-02 IN COMBINATION WITH THEIR ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) (SOFTWARE VERSION NOT PROVIDED). COMPLAINANT/COMPLAINT REPORTER NAME AND POSITION: (B)(6), MEDICAL TECHNOLOGIST. EVENT DATE: 03MAR2025. PATIENT INFORMATION: KNOWN TO HAVE A MIX OF ANTI-E(RH3) AND ANTI-JKA(JK1) ANTIBODIES SAMPLE ID (B)(6) REAGENTS: 0.8% SURGISCREEN (PRODUCT CODE 6902316; LOT VSS628; EXPIRY DATE 18MAR2025; MANUFACTURE DATE 14JAN2025) ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD 111224001-02 (PRODUCT CODE MTS084024; EXPIRY DATE 20AUG2025; MANUFACTURE DATE 20NOV2024) 0.8% SURGISCREEN (PRODUCT CODE 6902316; LOT VSS617; EXPIRY DATE 18FEB2025; MANUFACTURE DATE 17DEC2024) THE CUSTOMER REPORTED THAT ON (B)(6) 2025, THEY HAD TESTED SAMPLE ID (B)(6) FROM THIS PATIENT FOR ANTIBODY SCREENING IN IAT USING 0.8% SURGISCREEN LOT VSS617 AND ANTI-HUMAN GLOBULIN ANTI-IGG (RABB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761151 ↗
• MalfunctionMar 12, 2025False Negative Result; False Negative Result

  WINDCHILL CI0003987 CMS (B)(4) A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6)2025 AFTER OBSERVING WHAT WAS DESCRIBED AS A DISCORDANT NEGATIVE ANTIBODY SCREENING RESULTS IN INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT USING 0.8% SURGISCREEN FOR GEL LOT VSS622 AND ORTHO MTS ANTI-IGG CARD LOTS 060724001-22 AND 072224001-15 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZERS (B)(6). COMPLAINANT/COMPLAINT REPORTER: (B)(6); MEDICAL TECHNOLOGIST DATE OF EVENTS: 14 AND 19 FEB2025; REPORTED ON: (B)(6) 2025 BY CUSTOMER TO ORTHO GTSC REAGENTS: 0.8% SURGISCREEN LOT VSS622 EXPIRY DATE 04MAR2025, MANUFACTURE DATE 31DEC2024 ORTHO MTS ANTI-IGG CARD LOT 060724001-22 EXPIRY DATE 30APR2025, MANUFACTURE DATE 31JUL2024 ORTHO MTS ANTI-IGG CARD LOT 072224001-15 EXPIRY DATE 16MAY2025, MANUFACTURE DATE 16AUG2024 PATIENT INFORMATION: SAMPLE ID (B)(6)THE CUSTOMER STATED THAT ON (B)(6)2025, THEY HAD TESTED A PATIENT SAMPLE (SAMPLE ID (B)(6) FOR ANTIBODY SCREENING IN IAT USING 0.8% SURGISCREEN LOT VSS622 AND ORTHO MTS ANTI-IGG CARD LOT 060724001-22 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER (B)(6) AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE THREE CELLS OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582022 ↗
• MalfunctionNov 7, 2024False Negative Result; False Negative Result

  CMS (B)(4); WINDCHILL RA607944 ON 15OCT2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS A FALSE NEGATIVE ANTIBODY SCREEN RESULT FOR ONE PATIENT SAMPLE ON THEIR ORTHO VISION ID-MTS ANALYZER (50002397) USING 0.8% SURGISCREEN LOT: VSS591, EXPIRY 29OCT2024, IN CONJUNCTION WITH MTS ANTI-IGG GEL CARD LOT: 052224001-19, EXPIRY 08APR2025. COMPLAINANT: (B)(6); MEDICAL TECHNOLOGIST (B)(6); (B)(6) CUSTOMER: (B)(6), DATE OF EVENT: 02OCT2024 (REPORTED 15OCT2024) EQUIPMENT: ORTHO VISION ID-MTS ANALYZER SERIAL: (B)(6) SW VERSION: 5.12.4 (INSTALL DATE: ON (B)(6) 2017) REAGENTS: 0.8% SURGISCREEN LOT: VSS591, EXPIRY 29OCT2024, MANUFACTURED 27AUG2024 MTS ANTI-IGG GEL CARD LOT: 052224001-19, EXPIRY 08APR2024 0.8% RESOLVE PANEL A LOT: VRA468, EXPIRY 29OCT2024 0.8% RESOLVE PANEL C FICIN TREATED LOT: VRC328, EXPIRY 29OCT2024 PATIENT INFORMATION: PATIENT SAMPLE ID FROM ON (B)(6) 2024-(SAMPLE A): (B)(6) (ENCRYPTED: 7D-DF-A7-0E-7B-75-70-E9-5D-41-FA-29-06-65-61-3A-E9-1B-2C-FF-B3-ED-EF-05-13-BC-D8-53-61-CA-48-C8) PATIENT SAMPLE ID FROM ON (B)(6) 2024-(SAMPLE B): (B)(6) (ENCRYPTED: 87-47-49-25-97-19-29-7F-E1-96-30-55-CD-A4-70-97-93-4A-C9-16-B9-16-D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628651 ↗
• MalfunctionDec 28, 2023False Negative Result; False Negative Result

  CMS 2578032, WINDCHILL RA604459 ON (B)(6) 2023, A CUSTOMER COMPLAINED TO GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ABOUT WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE ANTIBODY SCREENING RESULTS IN THE INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT USING 0.8% SURGISCREEN LOT VSS506 AND MTS IGG CARD LOT 061223001-02 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS 50004387. COMPLAINANT/COMPLAINT REPORTER: (B)(6)¿ MEDICAL TECHNOLOGIST DATES OF EVENTS: (B)(6) 2023 REPORTED ON (B)(6) 2023 BY THE CUSTOMER TO GTSC. REAGENTS: 0.8% SURGISCREEN FOR GEL (PRODUCT CODE 6902316; LOT VSS506; EXPIRY DATE 28 NOVEMBER 2023, MANUFACTURED ON 26 SEPTEMBER 2023) MTS ANTI-IGG CARD (PRODUCT CODE; MTS084024; LOT 061223001-02; EXPIRY DATE 07 APRIL 2024, MANUFACTURED DATE 07 JULY 2023) OTHER REAGENT: 0.8% SURGISCREEN FOR GEL LOT VSS508 EXPIRY DATE 28 NOVEMBER 2023 0.8% RESOLVE PANEL A LOT VRA444, EXPIRY DATE 28 NOVEMBER 2023 PATIENTS¿ INFORMATION: SAMPLE IDS FOR PATIENT'S SAMPLES: -SAMPLE ID (B)(6) TESTED ON (B)(6) 2023. -SAMPLES IDS (B)(6) AND EC72845 WERE TESTED ON (B)(6) 2023. THE CUSTOMER REPORTED THAT ON (B)(6) 2023 THEY HAD TESTED A PATIENT SAMPLE (ID (B)(6) ) FOR ANTIBODY SCREENING IN IAT USING 0.8% SURGIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414957 ↗
• MalfunctionAug 23, 2023False Negative Result; False Negative Result

  REPORT 2 OF 2, (B)(4) ON (B)(6) 2023, A CUSTOMER COMPLAINED TO ORTHO CARE ABOUT WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE ANTIBODY SCREENING RESULTS IN THE INDIRECT ANTIGLOBULIN TEST (IAT) FOR TWO PATIENTS USING 0.8% SURGISCREEN LOT VSS479 IN CONJUNCTION WITH THEIR ORTHO WORKSTATION (B)(4). COMPLAINANT/COMPLAINT REPORTER: (B)(6) ¿ MEDICAL TECHNOLOGIST DATES OF EVENTS: NOT PROVIDED REPORTED ON (B)(6) TO ORTHO CARE HELPDESK SOFTWARE VERSION: N/AP REAGENTS: 0.8% SURGISCREEN LOT VSS479 EXPIRY DATE 08 AUGUST 2023 MTS ANTI-IGG CARD LOT 090622001-01 EXPIRY DATE 17 DECEMBER 2023 PATIENTS¿ INFORMATION: NOT PROVIDED. THE CUSTOMER REPORTED THAT THEY HAD TESTED 2 PATIENTS¿ SAMPLES WITH THEIR ALTERNATIVE COMPETITOR¿S COMMERCIALLY AVAILABLE INSTRUMENT METHOD AND THEY HAD OBTAINED POSITIVE RESULTS (1+ REACTION STRENGTH). NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT FOR CONFIRMATION OF THE OBTAINED RESULTS, THAT THEY HAD TESTED THE TWO PATIENTS¿ SAMPLES FOR ANTIBODY SCREENING IN IAT USING 0.8% SURGISCREEN LOT VSS479 AND MTS ANTI-IGG CARD LOT 090622001-01 IN MANUAL METHOD IN CONJUNCTION WITH THEIR ORTHO WORKSTATION ID-MTS J51001401 AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603697 ↗
• MalfunctionAug 23, 2023False Negative Result; False Negative Result

  REPORT 1 OF 2. MXP2545134 WINDCHILL RA603033 ON (B)(6) 2023, A CUSTOMER COMPLAINED TO ORTHO CARE ABOUT WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE ANTIBODY SCREENING RESULTS IN THE INDIRECT ANTIGLOBULIN TEST (IAT) FOR TWO PATIENTS USING 0.8% SURGISCREEN LOT VSS479 IN CONJUNCTION WITH THEIR ORTHO WORKSTATION ID-MTS J51001401. COMPLAINANT/COMPLAINT REPORTER: (B)(6) ¿ MEDICAL TECHNOLOGIST DATES OF EVENTS: NOT PROVIDED REPORTED ON (B)(6)2023 BY (B)(6) TO ORTHO CARE HELPDESK SOFTWARE VERSION: N/AP REAGENTS: 0.8% SURGISCREEN LOT VSS479 EXPIRY DATE 08 AUGUST 2023. MTS ANTI-IGG CARD LOT 090622001-01, EXPIRY DATE 17 DECEMBER 2023, PATIENTS¿ INFORMATION: NOT PROVIDED. THE CUSTOMER REPORTED THAT THEY HAD TESTED 2 PATIENTS¿ SAMPLES WITH THEIR ALTERNATIVE COMPETITOR¿S COMMERCIALLY AVAILABLE INSTRUMENT METHOD AND THEY HAD OBTAINED POSITIVE RESULTS (1+ REACTION STRENGTH). NO FURTHER DETAIL WAS PROVIDED. THE CUSTOMER REPORTED THAT FOR CONFIRMATION OF THE OBTAINED RESULTS, THAT THEY HAD TESTED THE TWO PATIENTS¿ SAMPLES FOR ANTIBODY SCREENING IN IAT USING 0.8% SURGISCREEN LOT VSS479 AND MTS ANTI-IGG CARD LOT 090622001-01 IN MANUAL METHOD IN CONJUNCTION WITH THEIR ORTHO WORKSTATION ID-MTS J51001401 A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603565 ↗
• MalfunctionApr 3, 2023False Negative Result; False Negative Result

  MXP2508999; RA601356 THE CUSTOMER REPORTED THAT, ON (B)(6) 2023, THEY HAD TESTED A SAMPLE FROM A PATIENT FOR ANTIBODY SCREENING IN THE INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% SURGISCREEN LOT: VSS440 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE 3 CELLS OF THE RED CELL REAGENT. THE CUSTOMER STATED THAT THEY WERE EXPECTING A POSITIVE REACTION AS THIS SAMPLE HAD COME FROM A NEARBY HOSPITAL FOR CONFIRMATION TESTING, AND THAT THE HOSPITAL HAD OBTAINED A POSITIVE ANTIBODY SCREENING RESULT. THE CUSTOMER REPORTED THAT, ON THE SAME DAY, THEY RETESTED THE SAME SAMPLE FOR MAJOR CROSSMATCH TESTING, AND THAT THEY HAD OBTAINED A WEAK POSITIVE 0.5+ REACTION USING LISS METHOD PROMPTING FURTHER INVESTIGATION. THE CUSTOMER STATED THAT THEY HAD REPEATED ANTIBODY SCREENING FOR THE SAME SAMPLE AND THAT THEY HAD OBTAINED A POSITIVE 1+ REACTION, AND THAT THEY WERE ABLE TO IDENTIFY AN ANTI-FYA(FY1) ANTIBODY. NO FURTHER DETAIL IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16668553 ↗
• MalfunctionApr 3, 2023False Negative Result; False Negative Result

  (B)(4); THE CUSTOMER REPORTED THAT, ON (B)(6) 2023, THEY HAD TESTED A SAMPLE FROM A PATIENT FOR ANTIBODY SCREENING IN THE INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% SURGISCREEN LOT VSS440 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE 3 CELLS OF THE RED CELL REAGENT. THE CUSTOMER STATED THAT THEY WERE EXPECTING A POSITIVE REACTION AS THIS SAMPLE HAD COME FROM A NEARBY HOSPITAL FOR CONFIRMATION TESTING, AND THAT THE HOSPITAL HAD OBTAINED A POSITIVE ANTIBODY SCREENING RESULT. THE CUSTOMER REPORTED THAT, ON THE SAME DAY, THEY RETESTED THE SAME SAMPLE FOR ANTIBODY SCREENING AND IDENTIFICATION IN TUBE METHOD, AND THAT THEY HAD OBTAINED POSITIVE (2-3+ WITH PEG AND SOLID PHASE) REACTIONS. THE CUSTOMER STATED THAT THEY WERE ABLE TO IDENTIFY AN ANTI-FYA(FY1) ANTIBODY. NO FURTHER DETAIL IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16668511 ↗
• MalfunctionApr 3, 2023False Negative Result; False Negative Result

  MXP2509360; (B)(4) THE CUSTOMER REPORTED THAT, ON (B)(6) 2023, THEY HAD TESTED A SAMPLE FROM A PATIENT FOR ANTIBODY SCREENING IN THE INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% SURGISCREEN LOT VSS436 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE 3 CELLS OF THE RED CELL REAGENT. THE CUSTOMER STATED THAT THEY WERE EXPECTING A POSITIVE REACTION AS THIS SAMPLE HAD COME FROM A NEARBY HOSPITAL FOR CONFIRMATION TESTING, AND THAT THE HOSPITAL HAD OBTAINED A POSITIVE ANTIBODY SCREENING RESULT. THE CUSTOMER REPORTED THAT, ON THE SAME DAY, THEY RETESTED THE SAME SAMPLE FOR ANTIBODY SCREENING AND IDENTIFICATION IN TUBE METHOD, AND THAT THEY HAD OBTAINED POSITIVE (1+ WITH LISS AND 2-3+ WITH PEG) REACTIONS. THE CUSTOMER STATED THAT THEY WERE ABLE TO IDENTIFY AN ANTI-C(RH4) ANTIBODY. NO FURTHER DETAIL IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16667648 ↗
• MalfunctionApr 3, 2023False Negative Result; False Negative Result

  (B)(4); (B)(4) THE CUSTOMER REPORTED THAT, ON (B)(6) 2023, THEY HAD TESTED A SAMPLE FROM PATIENT 1 FOR ANTIBODY SCREENING IN THE INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% SURGISCREEN LOT VSS436 IN MANUAL METHOD, AND THAT THEY HAD OBTAINED NEGATIVE REACTIONS WITH THE 3 CELLS OF THE RED CELL REAGENT. THE CUSTOMER STATED THAT THEY WERE EXPECTING A POSITIVE REACTION AS THIS SAMPLE HAD COME FROM A NEARBY HOSPITAL FOR CONFIRMATION TESTING, AND THAT THE HOSPITAL HAD OBTAINED A POSITIVE ANTIBODY SCREENING RESULT. THE CUSTOMER REPORTED THAT, ON THE SAME DAY, THEY RETESTED THE SAME SAMPLE FROM PATIENT 1 FOR ANTIBODY SCREENING AND IDENTIFICATION IN TUBE METHOD, AND THAT THEY HAD OBTAINED POSITIVE (2+ STRENGTH) REACTIONS WITH LISS AND PEG. THE CUSTOMER STATED THAT THEY WERE ABLE TO IDENTIFY AN ANTI-FYA(FY1) ANTIBODY. NO FURTHER DETAIL IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16664630 ↗
• MalfunctionMar 28, 2023False Negative Result; False Negative Result

  MXP2508827; RA601362 CUSTOMER REPORTED DISCREPANT NEGATIVE REACTION IN ANTIBODY SCREENING FOR ONE PATIENT SAMPLE USING 0.8% SURGISCREEN LOT: VSS436 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYSER. A 50-YEAR-OLD FEMALE PATIENT HAS A HISTORY OF BEING TRANSFUSED WITH 28 UNITS OF PACKED RED BLOOD CELLS BETWEEN DEC2022 TO FEB2023. A NEGATIVE ANTIBODY SCREEN WITH LOT: VSS436 WAS REPORTED TO THE CLINICIAN WITH PATIENT SAMPLE TESTED ON (B)(6) 2023. ON (B)(6) 2023, A FRESH SAMPLE FROM THE SAME PATIENT TESTED 1+ POSITIVE WITH CELL# 2 OF VSS441. ANTI-E WAS ABLE TO BE IDENTIFIED. CUSTOMER WAS ABLE TO RETEST PATIENT SAMPLE FROM ON (B)(6) 2023 WITH LOT: VSS441 AND THEY OBTAINED A 1+ POSITIVE REACTION WITH CELL# 2. CUSTOMER DETERMINED THAT A BIASED FALSE NEGATIVE ANTIBODY SCREEN RESULT WAS REPORTED TO THE CLINICIAN ON (B)(6) 2023. THEY HAVE SINCE INFORMED THE CLINICIAN OF THE CORRECT RESULT. THE CUSTOMER REPORTED THAT THE PATIENT WAS NOT HARMED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16631247 ↗
• DeathJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MXP2493870; RA600634 CUSTOMER REPORTED A PATIENT DEATH DUE TO NEGATIVE ANTIBODY SCREENING RESULTS. TESTING WAS PERFORMED ON THREE ORTHO VISION ANALYZERS ON (B)(6) 2021, (B)(6) 2021 AND (B)(6) 2021 AND NEGATIVE ANTIBODY SCREENING RESULTS WERE CONFIRMED. COLD AGGLUTINATION STUDIES WERE PERFORMED AND A COLD ANTIBODY WAS IDENTIFIED INCLUDING A POSITIVE AUTOCONTROL WHICH BECAME NEGATIVE AT 30 DEGREES C. PATIENT WITH HISTORY OR BREAST CANCER AND MITRAL REGURGITATION OF PULMONARY VEIN, WAS TAKEN TO SURGERY ON (B)(6) 2021. AFTER A MASSIVE TRANSFUSION PROTOCOL WAS ACTIVATED, THE PATIENT EXPIRED DURING SURGERY. CUSTOMER INDICATES THAT THE PATIENT WAS ALREADY IN DEMISE BEFORE ANY TRANSFUSION AND THAT THE PATIENT'S DEATH WAS NOT TRANSFUSION RELATED. ORTHO INVESTIGATION: BATCH RECORD REVIEW AND A COMPLAINT REVIEW WERE PERFORMED. RETAIN SAMPLES HAD ALREADY EXPIRED. ALL RESULTS WERE AS EXPECTED. THE ORDER REPORTS FOR TESTING PERFORMED ON THE CUSTOMER'S ORTHO VISION ID-MTS ANALYZERS WERE REQUESTED BUT WERE NOT PROVIDED BY THE CUSTOMER. ORTHO'S MEDICAL SAFETY OFFICER WAS CONSULTED ON THIS CASE AND PROVIDED THE FOLLOWING RESPONSE: BASED ON THE AVAILABLE INFORMATION, MULTIPLE TYPE AND SCREENING TESTS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16215744 ↗
• DeathJan 20, 2023False Negative Result; False Negative Result

  (B)(4) INVESTIGATION: AS PART OF THE INVESTIGATION, RETAIN TESTING FOR VSS420, BATCH RECORD REVIEW AND COMPLAINT REVIEW WERE PERFORMED. ALL RESULTS MET CRITERIA AND ORTHO WAS UNABLE TO REPRODUCE THE EVENT. AN ORTHO FIELD ENGINEER WENT ON SITE ON (B)(4) 2022, PERFORMED THE FOLLOWING CHECKS - INCUBATOR, CENTRIFUGE AND FLUIDIC SYSTEM - AND CONFIRMED THE ANALYZER WAS WORKING AS INTENDED. AN ORTHO 2ND LEVEL PERSONNEL WENT ON SITE ON (B)(4) 2023 TO: COLLECT INFORMATION FROM THE CUSTOMER AND INTERNAL REPORTS TO INSPECT THE SAMPLES PROVIDED BY THE CUSTOMER (FOR THIS ISSUE AND THAT OF CMS (B)(4)) -TO RUN QC THAT PASSED -TO PULL LABORATORY INFORMATION SYSTEM LOGS FILES, COMMON LOGS (UPLOADED TO AXEDA) AND SCREENSHOTS FROM THE ANALYZER SETTINGS CONFIGURATION. FURTHER INVESTIGATION WAS PERFORMED BY ORTHO 2ND LEVEL. THREE DOCUMENTS WERE CREATED BY ORTHO PERSONNEL AND WERE SHARED WITH THE CUSTOMER DURING A CONFERENCE CALL THAT WAS HELD ON (B)(6) 2023. THESE DOCUMENTS SUMMARIZE THE TIMELINE AND SEQUENCE OF THE 2 EVENTS IN QUESTION (CMS (B)(4)) AS ORTHO UNDERSTAND THEM. THEY WERE DEVELOPED FROM VARIOUS SOURCES OF DATA, WHICH INCLUDE BUT NOT LIMITED TO INFORMATION IN THE COMPLAINT FILES, INFORMATIO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16214233 ↗
• MalfunctionJan 17, 2023False Negative Result; False Negative Result

  (B)(4). CUSTOMER COMPLAINED TO ORTHO CARE ABOUT WHAT WAS DESCRIBED AS A DISCREPANT NEGATIVE ANTIBODY SCREENING RESULT IN THE INDIRECT ANTIGLOBULIN TEST (IAT) FOR ONE PATIENT¿¿S SAMPLE USING 0.8% SURGISCREEN LOT VSS420 AND MTS ANTI-IGG CARD LOT 040622001-02 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER J50002261. PATIENT HAD HISTORY OF BLOOD GROUP O RHD NEGATIVE AND NEGATIVE ANTIBODY SCREENING, NO HISTORY OF TRANSFUSION. THE CUSTOMER REPORTED THAT A NEGATIVE ANTIBODY SCREENING RESULT HAD BEEN REPORTED TO THE PHYSICIAN AND THAT A UNIT OF PACKED RED BLOOD CELLS WAS ISSUED USING ELECTRONIC CROSSMATCH AND TRANSFUSED TO THE PATIENT. THE CUSTOMER REPORTED THAT FOLLOWING ANOTHER INCIDENT ON WHICH OCCASION THEY MISSED AN ANTI-K ANTIBODY (SEE CMS (B)(4)), THAT ON (B)(6) 2022, THEY HAD TESTED A SAMPLE FROM THIS PATIENT FOR ANTIBODY SCREENING IN INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% SURGISCREEN LOT VSS427 AND MTS ANTI-IGG CARD LOT 06132201-03 IN CONJUNCTION WITH THEIR VISION ID-MTS ANALYZER AND THAT THEY OBTAINED A POSITIVE REACTION (3+ REACTION STRENGTH) WITH CELL 3 AND NEGATIVE REACTIONS CELLS 1 AND 2 OF THE RED CELL REAGENT. THE CUSTOMER REPORTED THEY WERE ABLE TO IDENTIFY A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16187336 ↗