ORTHO 6904577 (UDI 10758750012817)Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 10758750012817), received between Nov 18, 2022 and Apr 13, 2026 — classified as 4 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (73 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 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Imprecise or Erratic Results

  CMS (B)(4)/ RA614139 ON (B)(6) 2026, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT RESULTS FOR ONE PATIENT SAMPLE FOR ABO FORWARD AND REVERSE GROUP TESTING ON THEIR ORTHO VISION ID-MTS ANALYZER (SERIAL (B)(6) IN CONJUNCTION WITH MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 082925037-20 AND 0.8% AFFIRMAGEN LOT 8A093. COMPLAINANT: (B)(6) CUSTOMER (B)(6) THR - (B)(6) DATE OF EVENT: 20MAR2026, REPORTED ON THE SAME DAY EQUIPMENT: ORTHO VISION ID-MTS, S/N (B)(6) SOFTWARE VERSION: 5.16.0, INSTALL DATE: (B)(6) 2017 REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 082925037-20, EXPIRY DATE: 10JUL2026 0.8% AFFIRMAGEN LOT 8A833, EXPIRY DATE: 28APR2026 PATIENT INFORMATION: SAMPLE A (INITIAL SAMPLE) SAMPLE ID: (B)(6); ENCRYPTED ID (B)(4) SAMPLE B (CONFIRMATION SAMPLE) SAMPLE ID: (B)(6); ENCRYPTED ID (B)(4) SAMPLE C (REDRAW) SAMPLE ID: (B)(6); ENCRYPTED ID (B)(4) NO KNOWN HISTORY, NO PRIOR TRANSFUSIONS, PATIENT DIAGNOSIS WAS SYNCOPE. THE CUSTOMER REPORTED THAT ON (B)(6) 2026, A PATIENT SAMPLE (SAMPLE A) WAS TESTED FOR ABO FORWARD AND REVERSE TYPING USING MTS ABD MONOCLONAL AND REVERSE GROUPING GEL CARD LOT 08292

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858662 ↗
• InjuryOct 15, 2025Leak/Splash; Leak/Splash

  (B)(4) / RA612304 THE CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2025 TO REPORT WHAT WAS DESCRIBED AS AN INDIRECT LIQUID SPLASH IN THE EYES WITH LIQUID FROM THE WASTE CONTAINER COMING FROM THE ORTHO VISION ID-MTS ANALYZER (B)(6). COMPLAINANT: (B)(6), MEDICAL TECHNOLOGIST (B)(6) USA DATE OF THE EVENT: 22SEP2025, REPORTED ON (B)(6) 2025. INSTRUMENT: ORTHO VISION ID-MTS - (B)(6), INSTALL DATE: (B)(6) 2017 SW VERSION: 5.16.0 THE CUSTOMER REPORTED THAT ON (B)(6) 2025, THE OPERATOR UNCAPPED THE LIQUID WASTE CONTAINER AT THE SINK IMMEDIATELY BEFORE DISPOSAL, AND WHILE DUMPING THE LIQUID WASTE IN THE SINK, A SMALL AMOUNT OF FLUID SPLASHED UPWARD AND INTO THE OPERATOR'S EYES. THE OPERATOR IMMEDIATELY RINSED THEIR EYES THOROUGHLY WITH WATER AT THE BATHROOM SINK. THE CUSTOMER REPORTED NO TREATMENT OR MEDICATION WAS ADMINISTERED, AND THE INCIDENT WAS REPORTED TO THEIR INTERNAL EMPLOYEE HEALTH AND SAFETY DEPARTMENT FOR FOLLOW UP. THE CUSTOMER REPORTED THE OPERATOR DID NOT WEAR PERSONAL PROTECTIVE EQUIPMENT (GLASSES), AS A SPLASH SHIELD WAS IN USE. THE CUSTOMER CONFIRMED THAT THE OPERATOR IS IN STABLE CONDITION. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286372 ↗
• InjuryAug 12, 2025Leak/Splash; Leak/Splash

  CMS (B)(4) RA611526 THE CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2025 TO REPORT WHAT WAS DESCRIBED AS LIQUID SPLASHED IN THE EYES FROM A CONNECTED TUBING WITH LIQUID COMING FROM WASH STATION OF THE ORTHO VISION BIOVUE ANALYZER (B)(6). INJURED PERSON / COMPLAINT REPORTER: ILARIA LUCCHERINI, LABORATORY TECHNICIAN DATE OF THE EVENT: 24 JUNE 2025 IN THE MORNING. THE CUSTOMER REPORTED THAT ON (B)(6) 2025 IN THE MORNING, WHEN DISCONNECTING THE TUBING FROM THE LATERAL SIDE OF THE ORTHO VISON BIOVUE ANALYZER (B)(6), SHE HAS RECEIVED SOME SPLASHED LIQUID IN HER EYES. THE LIQUID IN THIS TUBING IS COMING FROM THE WASH STATION OF THE ORTHO VISION BIOVUE ANALYZER (B)(6). THE CUSTOMER REPORTED THAT NO PATIENTS SAMPLES WERE TESTED THAT MORNING. THE CUSTOMER REPORTED THAT SHE DID NOT WEAR PERSONAL PROTECTIVE EQUIPMENT (GLASSES). THE CUSTOMER REPORTED THAT SHE HAD CONSULTED A MEDICAL DOCTOR AND NO TREATMENT WAS REQUIRED. THE CUSTOMER DID NOT REQUIRE ANY ABSENCE FROM WORK. THE CUSTOMER REPORTED THAT SHE IS VACCINATED AGAIN HEPATITIS B AND THAT NO FURTHER PREVENTIVE TREATMENT WAS PROVIDED. THE CUSTOMER CONFIRMED THAT NO FURTHER ACTION WAS REQUIRED, AND THAT SHE DID NOT REQ

  Patient problems: Exposure to Body Fluids

  MAUDE report 22781733 ↗
• MalfunctionMar 31, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CMS 100106812 AND 100106884 WINDCHILL RA609403 A REPORT TO BE FILED FOR EACH ANALYZER. (2 IN TOTAL) ON (B)(6) 2025, A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT THE USE OF 10% FORMALIN IN PLACE OF BLOOD BANK SALINE AND THE ORTHO VISION ANALYZERS (SERIAL NUMBER: (B)(6) DID NOT PRODUCE A SYSTEM ERROR. COMPLAINANT: (B)(6), (MEDICAL TECHNOLOGIST), (B)(6), CUSTOMER: (B)(6); PROSPECT: (B)(6), DATE OF EVENTS: 13MAR2025, REPORTED ON SAME DAY ANALYZER 1: ORTHO VISION ID-MTS ANALYZER (B)(6), INSTALLED: ON (B)(6) 2015 SOFTWARE VERSION: 5.16.0 SYSTEM FLUIDS: EXPECTED - BUFFERED SALINE ACTUAL - 10% FORMALIN SOLUTION ANALYZER 2: ORTHO VISION ID-MTS ANALYZER (B)(6), INSTALLED: ON (B)(6) 2015 SOFTWARE VERSION: 5.16.0 SYSTEM FLUIDS: EXPECTED - BUFFERED SALINE ACTUAL - 10% FORMALIN SOLUTION THE CUSTOMER REPORTED NO ERRONEOUS PATIENT RESULTS WERE OBTAINED. THE CUSTOMER STATED THAT NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE CUSTOMER STATED THAT NO PATIENT WAS HARMED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729198 ↗
• MalfunctionMar 28, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  CMS (B)(4) WINDCHILL RA609403 A REPORT TO BE FILED FOR EACH ANALYZER. (2 IN TOTAL) ON (B)(6) 2025, A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT THE USE OF 10% FORMALIN IN PLACE OF BLOOD BANK SALINE AND THE ORTHO VISION ANALYZERS (SERIAL NUMBER (B)(6) DID NOT PRODUCE A SYSTEM ERROR. COMPLAINANT: (B)(6) (MEDICAL TECHNOLOGIST)(B)(6) CUSTOMER (B)(6); (B)(6) MEDICAL CENTER, (B)(6) DATE OF EVENTS: 13MAR2025, REPORTED ON SAME DAY ANALYZER 1: ORTHO VISION ID-MTS ANALYZER (B)(6), INSTALLED: ON (B)(6) 2015 SOFTWARE VERSION: 5.16.0 SYSTEM FLUIDS: EXPECTED - BUFFERED SALINE ACTUAL - 10% FORMALIN SOLUTION ANALYZER 2: ORTHO VISION ID-MTS ANALYZER (B)(6), INSTALLED: ON (B)(6) 2015 SOFTWARE VERSION: 5.16.0 SYSTEM FLUIDS: EXPECTED - BUFFERED SALINE ACTUAL - 10% FORMALIN SOLUTION THE CUSTOMER REPORTED NO ERRONEOUS PATIENT RESULTS WERE OBTAINED. THE CUSTOMER STATED THAT NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE CUSTOMER STATED THAT NO PATIENT WAS HARMED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717964 ↗
• MalfunctionMar 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CMS (B)(4) WINDCHILL RA609373 COMPLAINT DESCRIPTION: A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2025 TO REPORT DISCORDANT RESULTS IN ABO/RH ANTIGEN TYPING, ABO REVERSE TYPING AND ANTIBODY SCREENING IN INDIRECT ANTIGLOBULIN TEST (IAT) OBTAINED WITH THEIR ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) EQUIPPED WITH SOFTWARE VERSION 5.16.0. COMPLAINANT/COMPLAINT REPORTER NAME AND POSITION: (B)(6), MEDICAL TECHNOLOGIST. EVENT DATE: 27FEB2025. REAGENTS: MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 102524037-01 (EXPIRY DATE 28JUL2025, MANUFACTURE DATE 28OCT2024) MTS DILUENTS 2 PLUS LOT MDP244 (EXPIRY DATE 13AUG2025, MANUFACTURE DATE 13AUG2024) 0.8% AFFIRMAGEN LOT 8A884 (EXPIRY DATE 04MAR2025, MANUFACTURE DATE 17DEC2024) 0.8% SELECTOGEN LOT VS684 (EXPIRY DATE 18MAR2025, MANUFACTURE DATE 14JAN2025) MTS ANTI-IGG CARD LOT 092024001-11 (EXPIRY DATE 17JUL2025; MANUFACTURE DATE 17OCT2024). PATIENT INFORMATION: SAMPLE ID (B)(6); PATIENT ID(B)(6) 58-YEAR-OLD FEMALE. THE CUSTOMER REPORTED THAT ON (B)(6)2025, THEY TESTED SAMPLE ID (B)(6) FROM THIS PATIENT FOR ABO/RH ANTIGEN TYPING, ABO REVERSE TYPING AND ANTIBODY SCREENING IN IAT IN COMBINATION WITH THEIR ORTHO VISION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702251 ↗
• MalfunctionMar 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CMS: 100086868, WINDCHILL: RA609246 ON (B)(6) 2025, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT RESULTS FOR ONE PATIENT SAMPLE FOR ABO FORWARD AND REVERSE GROUP TESTING ON THEIR ORTHO VISION ID-MTS ANALYZER (SERIAL: (B)(6) IN CONJUNCTION WITH MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT: 102524037-16 AND 0.8% AFFIRMAGEN LOT: 8A900. COMPLAINANT: (B)(6); CUSTOMER#: (B)(6); (B)(6); DATE OF EVENT: 24FEB2025, REPORTED ON 25FEB2025 EQUIPMENT: ORTHO VISION ID-MTS ANALYZER SERIAL: (B)(6) SOFTWARE VERSION: 5.16.0 INSTALL DATE: ON (B)(6) 2024 REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT: 102524037-16, EXPIRATION: 16AUG2025 0.8% AFFIRMAGEN LOT: 8A900, EXPIRATION: 01APR2025, PATIENT INFORMATION: SAMPLE: (B)(6) (INITIAL SAMPLE) SAMPLE ID: (B)(6) (ENCRYPTED SAMPLE ID: (B)(6); SAMPLE: (B)(6) (CONFIRMATION SAMPLE) SAMPLE ID: (B)(6) (ENCRYPTED SAMPLE ID: (B)(6); HISTORICAL BLOOD TYPE: A POSITIVE THE CUSTOMER REPORTED THAT ON (B)(6) 2025, THEY HAD TESTED ONE PATIENT SAMPLE (SAMPLE: (B)(6) FOR ABO FORWARD AND REVERSE TYPING USING MTS ABD MONOCLONAL AND REVERSE GROUPING GEL CARD LOT: 102524037-16 AND 0.8% AFFIRMAGEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619509 ↗
• MalfunctionMar 4, 2025False Positive Result; False Positive Result

  CMS 100064440, WINDCHILL RA609067, ON (B)(6) 2025, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT A CARD/CASSETTE IMAGING SYSTEM (CIMS) MISREAD OF THEIR ORTHO VISION ID-MTS (SERIAL NUMBER: (B)(6) OF THE ANTI-A COLUMN DURING A/B/D GROUP TESTING FOR ONE CORD SAMPLE FROM A NEWBORN. THE CUSTOMER STATED THE POSITIVE RESULT GENERATED BY THE INSTRUMENT SHOULD HAVE BEEN NEGATIVE. COMPLAINANT: (B)(6); MEDICAL TECHNOLOGIST; (B)(6) DATE OF EVENT: 06 FEBRUARY 2025 VISION (B)(6); SOFTWARE VERSION: 5.15.0.47622 REAGENTS: MTS ABD MONOCLONAL GROUPING CARD LOT: 022324053-08, EXPIRY 28 FEBRUARY 2025 MTS DILUENT 2 PLUS LOT: 241, EXPIRY 05 JUNE 2025 MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT: 100424037-17, EXPIRY 24 JULY 2025 0.8% AFFIRMAGEN CELLS LOT: 8A886, EXPIRY DATE 4 MARCH 2025. NEWBORN INFORMATION: MALE, NEWBORN LESS THAN ONE MONTH. MOTHER IS 0 D (RH1) NEGATIVE. NEWBORN SAMPLE ID IS (B)(6). NEWBORN PATIENT ID IS (B)(6). NEWBORN BLOOD CORD SAMPLE WAS TESTED FOR DAT (DIRECT ANTIGLOBULIN TEST) AND FOUND DAT POSITIVE (NO FURTHER INFORMATION WAS PROVIDED). THE CUSTOMER STATED THAT ON (B)(6) 2025 AT 17H48, A CORD BLOOD SAMPLE FROM A NEWBORN WAS TESTED FOR ABO-RH USI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21519421 ↗
• MalfunctionDec 11, 2024False Positive Result; False Positive Result

  CMS (B)(4), WINDCHILL RA608416 ON (B)(6) 2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT RESULTS FOR ONE PATIENT SAMPLE FOR ABO FORWARD AND REVERSE GROUP TESTING ON THEIR ORTHO VISION ID-MTS ANALYZER (SERIAL(B)(6) IN CONJUNCTION WITH MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 080224037-12 AND 0.8% AFFIRMAGEN LOT 8A842. COMPLAINANT: (B)(4) LAW; MEDICAL TECHNOLOGIST (B)(6) CUSTOMER (B)(6) DATE OF EVENT: 21NOV2024, REPORTED SAME DAY EQUIPMENT: ORTHO VISION ID-MTS ANALYZER SERIAL: (B)(6) SOFTWARE VERSION: 5.16.0 INSTALL DATE: 18JUN2020 REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 080224037-12 (EXPIRY 10MAY2025) 0.8% AFFIRMAGEN LOT 8A842 (EXPIRY 26NOV2024) PATIENT INFORMATION: SAMPLE ID (B)(6) (ENCRYPTED SAMPLE ID:(B)(6). HISTORICAL BLOOD TYPE: O POSITIVE REPEAT TESTING PERFORMED WITH SAME SAMPLE, UTILIZING AN ALTERNATE SAMPLE ID: (B)(6) THE CUSTOMER REPORTED THAT ON (B)(6) 2024, THEY HAD TESTED ONE PATIENT SAMPLE FOR ABO FORWARD AND REVERSE TYPING USING MTS ABD MONOCLONAL AND REVERSE GROUPING GEL CARD LOT 080224037-12 AND 0.8% AFFIRMAGEN LOT 8A842 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903562 ↗
• MalfunctionNov 27, 2024Contamination; Contamination

  CMS 2666266, WINDCHILL RA608205 ON 07NOV2024, A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT FALSE POSITIVE ANTIBODY SCREENING RESULTS ON THE ORTHO VISION ID-MTS ANALYZER. DURING TROUBLESHOOTING, IT WAS IDENTIFIED THAT THE OPERATOR POTENTIALLY USED METHANOL IN PLACE OF BLOOD BANK SALINE AND THE ORTHO VISION ANALYZER (SERIAL NUMBER: (B)(6) DID NOT PRODUCE A SYSTEM ERROR. COMPLAINANT: (B)(6) (MEDICAL TECHNOLOGIST) (B)(6); NO EMAIL PROVIDED CUSTOMER (B)(6); (B)(6) DATE OF EVENTS: INITIAL EVENT 06NOV2024, REPORTED 07NOV2024. SECOND EVENT 13NOV2024, IDENTIFIED AND DOCUMENTED BY ORTHO FSE SAME DAY. ORTHO VISION MTS ANALYZER (B)(4), INSTALLED: ON (B)(6) 2021, MANUFACTURED: 12OCT2020 SOFTWARE VERSION: 5.16.0 SYSTEM FLUIDS: EXPECTED - BUFFERED SALINE ACTUAL - EVENT 1: METHANOL SOLUTION AND EVENT 2: FORMALIN THE CUSTOMER REPORTED THAT ERRONEOUS POSITIVE ANTIBODY SCREEN PATIENT RESULTS WERE OBTAINED ON THE ORTHO VISION ANALYZER; HOWEVER, UPON REPEAT IN MANUAL GEL METHOD, NEGATIVE RESULTS WERE OBSERVED. THE CUSTOMER STATED THAT NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT NO PATIENT WAS HARMED AS A CONSEQUENCE OF THE REPORTED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795253 ↗
• MalfunctionNov 27, 2024False Positive Result; False Positive Result

  (B)(6)2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT RESULTS FOR ONE PATIENT SAMPLE FOR ABO FORWARD AND REVERSE GROUP TESTING ON THEIR ORTHO VISION ID-MTS ANALYZER (SERIAL (B)(6)) IN CONJUNCTION WITH MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 061424037-26 AND (B)(4) AFFIRMAGEN LOT 8A833. COMPLAINANT: (B)(6); MEDICAL TECHNOLOGIST (B)(6) DATE OF EVENT: 04NOV2024, REPORTED (B)(6)2024 EQUIPMENT: ORTHO VISION ID-MTS SERIAL: (B)(6) SOFTWARE VERSION: 5.16.0 INSTALL DATE: (B)(6)2020, MANUFACTURED: 24AUG2020 REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 061424037-26, EXPIRY DATE: 10MAY2025 (B)(4) (B)(6) THE CUSTOMER REPORTED THAT ON (B)(6)2024, THEY HAD TESTED ONE PATIENT SAMPLE (SAMPLE A) FOR ABO FORWARD AND REVERSE TYPING USING MTS ABD MONOCLONAL AND REVERSE GROUPING GEL CARD LOT 061424037-26 AND (B)(4) AFFIRMAGEN LOT 8A833 IN CONJUNCTION WITH THEIR ORTHO VISION ID-MTS ANALYZER AND THAT THEY OBTAINED A B POSITIVE RESULT. THE CUSTOMER REPORTED THAT ON (B)(6)2024, THEY TESTED A NEW CONFIRMATION SAMPLE FROM THE SAME PATIENT (SAMPLE B) FOR ABO FORWARD AND REVERSE TYPING USING MTS ABD MONOCLONAL AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20794582 ↗
• MalfunctionNov 12, 2024Contamination; Contamination

  CMS (B)(4), WINDCHILL RA608034 COMPLAINT DESCRIPTION: ON 22OCT2024, A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT THAT THE OPERATOR USED OF 70% ALCOHOL IN PLACE OF DEIONIZED (DI) WATER WHEN REFILLING THE CONTAINER AND THE ORTHO VISION ID-MTS ANALYZER (SERIAL NUMBER (B)(6)) DID NOT PRODUCE A SYSTEM ERROR. COMPLAINANT: (B)(6); (B)(6) HOSPITAL ((B)(6)); (B)(6), CANADA L6A 423 DATE OF EVENTS: 16OCT2024 AT APPROXIMATELY 09:21AM THROUGH 21OCT2024, REPORTED 22OCT2024. ORTHO VISION MTS ANALYZER (B)(6), INSTALLED: 19MAY2022 SOFTWARE VERSION: 5.15.0 SYSTEM FLUIDS: EXPECTED - DEIONIZED (DI) WATER ACTUAL - 70% ALCOHOL THE CUSTOMER REPORTED THAT NO ERRONEOUS QUALITY CONTROL (QC) OR PATIENT RESULTS WERE OBTAINED BETWEEN (B)(6) 2024. THE CUSTOMER STATED THAT NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT NO PATIENT WAS HARMED AS A CONSEQUENCE OF THE REPORTED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662229 ↗
• MalfunctionNov 5, 2024Contamination; Contamination

  CMS 2661010, WINDCHILL RA608032 COMPLAINT DESCRIPTION: ON (B)(6) 2024, A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT FALSE POSITIVE ANTIBODY SCREENING RESULTS ON THE ORTHO VISION ID-MTS ANALYZER. DURING TROUBLESHOOTING, IT WAS IDENTIFIED THAT THE OPERATOR USED OF 10% FORMALIN IN PLACE OF BLOOD BANK SALINE AND THE ORTHO VISION ANALYZER (SERIAL NUMBER: (B)(6) DID NOT PRODUCE A SYSTEM ERROR. COMPLAINANT: (B)(6) (LABORATORY TECHNOLOGIST) (B)(6); (B)(6) CUSTOMER (B)(6); (B)(6) HEALTHCARE; (B)(6) DATE OF EVENTS: 17OCT2024 AT APPROXIMATELY 19:30PM THROUGH 18OCT2024, REPORTED 18OCT2024. ORTHO VISION MTS ANALYZER (B)(6), INSTALLED: ON (B)(6), 2019 SOFTWARE VERSION: 5.12.4.46568 SYSTEM FLUIDS: EXPECTED - BUFFERED SALINE ACTUAL - 10% FORMALIN SOLUTION THE CUSTOMER REPORTED THAT NO ERRONEOUS ANTIBODY SCREEN PATIENT RESULTS WERE OBTAINED; HOWEVER, UPON REPEAT IN MANUAL GEL METHOD, NEGATIVE RESULTS WERE OBSERVED. THE CUSTOMER STATED THAT NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT NO PATIENT WAS HARMED AS A CONSEQUENCE OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613045 ↗
• MalfunctionSep 27, 2024Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  CMS (B)(4), WINDCHILL RA607512 COMPLAINT DESCRIPTION: ON (B)(6) 2024, A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT THE USE OF 10% FORMALIN IN PLACE OF BLOOD BANK SALINE AND THE ORTHO VISION ANALYZER (SERIAL NUMBER (B)(6) DID NOT PRODUCE A SYSTEM ERROR. COMPLAINANT: (B)(6) (MEDICAL TECHNOLOGIST) (B)(6) ; (B)(6) MEDICAL CENTER (B)(6); DATE OF EVENTS: 30AUG2024 AT APPROXIMATELY 21:00 PM THROUGH 31AUG2024, REPORTED ON (B)(6) 2024. ORTHO VISION MTS ANALYZER (B)(6), INSTALLED: ON (B)(6) 2021 SOFTWARE VERSION: 5.12.4.46568 SYSTEM FLUIDS: EXPECTED - BUFFERED SALINE ACTUAL - 10% FORMALIN SOLUTION THE CUSTOMER REPORTED THAT NO ERRONEOUS OR DISCREPANT PATIENT RESULTS WERE OBTAINED. THE CUSTOMER STATED THAT NO BIASED RESULTS WERE REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT NO PATIENT WAS HARMED AS A CONSEQUENCE OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321956 ↗
• MalfunctionSep 26, 2024False Positive Result; False Positive Result

  CMS (B)(4) ; WINDCHILL RA607531 ON (B)(6) 2024, A CUSTOMER CONTACTED THE GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT A CASSETTE IMAGING SUBSYSTEM (CIMS) MISREAD OF THEIR ORTHO VISION ID-MTS (SERIAL NUMBER: (B)(6) OF THE ANTI-D COLUMN DURING A/B/D AND REVERSE GROUP TESTING FOR TWO SAMPLES OF ONE PATIENT. THE CUSTOMER STATED THE POSITIVE RESULTS GENERATED BY THE INSTRUMENT SHOULD HAVE BEEN MF (MIXED FIELD). COMPLAINANT: (B)(6); MEDICAL TECHNOLOGIST; (B)(6) . CUSTOMER (B)(6); (B)(6) HEALTH DATES OF EVENT: 02SEP2024 VISION 50004412; SOFTWARE VERSION: 5.15.0.47622 (INSTALLED (B)(6) 2023) REAGENTS: MTS ABD MONOCLONAL AND REVERSE CARD LOT 051424037-18 NO ADDITIONAL DETAILS PROVIDED. PATIENT INFORMATION: MALE, ABORH HISTORIC TYPE OF A NEGATIVE. TRANSFUSED 2 UNITS OF O POSITIVE BLOOD ON (B)(6) 2024. SAMPLE IDS: -(B)(6) : 6A-78-0B-0B-F9-CA-DE-02-8E-66-4B-E9-48-4C-CC-FA-33-03-1A-DA-54-00-76-66-66-22-EC-08-17-16-E9-2F (PRE-TRANSFUSION SAMPLE) -(B)(6): 4A-7D-72-04-3D-04-8C-3B-A1-4B-32-40-80-8D-F3-48-5D-67-FB-3D-B7-39-2E-FF-04-E4-EF-A0-A7-91-8C-92 (SAMPLE 1) -(B)(6): E0-CC-4B-49-8B-BE-2E-28-0F-58-6E-8F-02-73-CD-36-CF-9C-60-3E-2C-42-CA-58-82-F3-66-C6-55-E1-57-88 (SAMPLE 2) THE CUSTOMER STA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20308567 ↗
• InjuryAug 27, 2024Leak/Splash; Leak/Splash

  (B)(4), WINDCHILL (B)(4) A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON 30 JULY 2024 TO REPORT THAT WHILE MANUALLY REMOVING A DISPENSED CASSETTE FROM THE GRIPPER FINGERS, THE OPERATOR GOT SPLASH OF LIQUID CONTAINED IN THE CASSETTE IN ONE EYE. COMPLAINT REPORTER NAME AND POSITION: (B)(6), LABORATORY SUPERVISOR EVENT DATE: 30 JULY 2024 REAGENTS: ORTHO BIOVUE REVERSE DILUENT CASSETTE; LOT RDC123F; EXPIRY DATE 10 APRIL 2025 0.8% AFFIRMAGEN; LOT 84A414; EXPIRY DATE 06 AUGUST 2024 THE CUSTOMER REPORTED THAT DUE TO AN ERROR APSW000 (DETAIL GRIP1_8100) WHERE A DISPENSED CASSETTE GOT STUCK IN THE GRIPPER FINGERS, THE OPERATOR REMOVED THE CASSETTE MANUALLY BY PULLING HARDLY RATHER THAN USING THE BLUE WHEEL TO OPEN THE GRIPPER FINGERS AS RECOMMENDED AND GOT LIQUID FROM THE CASSETTE SPLASHED IN ONE EYE. THE CUSTOMER REPORTED THAT OPERATOR WAS TAKEN A BLOOD SAMPLE TO SCREEN VIRAL MARKERS AND OTHER LABORATORY EXAMS. NO FURTHER DETAILS WILL BE PROVIDED DUE TO PRIVACY CONCERNS. THE CUSTOMER REPORTED THAT THE OPERATOR WENT TO THE HOSPITAL AND GOT PRESCRIBED A SICKNESS LEAVE OF FIVE DAYS. THE CURRENT HEALTH STATE OF THE OPERATOR IS FINE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 20075178 ↗
• MalfunctionAug 9, 2024False Positive Result; False Positive Result

  CMS 2637276, WINDCHILL (B)(4) A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON 17 JULY 2024 TO REPORT A DISCREPANT ABO BLOOD TYPE OBTAINED WITH THEIR ORTHO VISION ID-MTS ANALYZER (SERIAL (B)(6) EQUIPPED WITH SOFTWARE VERSION 5.15.0. COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), LABORATORY SUPERVISOR. EVENT DATE: 17 JULY 2024. REAGENTS: MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD (PRODUCT CODE MTS080515; LOT 041924037-01; EXPIRY DATE 22 JANUARY 2025; MANUFACTURE DATE 22 APRIL 2024) 0.8% AFFIRMAGEN (PRODUCT CODE 719201; LOT 8A783; EXPIRY DATE 23 JULY 2024; MANUFACTURE DATE 07MAY 2024) PATIENT: ID (B)(6) KNOWN TO BE O RHD POSITIVE THE CUSTOMER REPORTED THAT ON 17 JULY 2024, SAMPLE ID (B)(6) FROM A PATIENT WAS TESTED FOR ABO FORWARD AND REVERSE AND D (RH1) ANTIGEN USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 012624037-11 AND 0.8% AFFIRMAGEN LOT 8A783 IN COMBINATION WITH THEIR ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) AND THAT THEY HAD OBTAINED A BLOOD GROUP AB RHD POSITIVE. THE CUSTOMER REPORTED THAT AS THIS PATIENT WAS KNOWN TO BE BLOOD GROUP O RHD POSITIVE, THEY HAD RE-TESTED THE SAME SAMPLE TUBE IN MANUAL METHOD AND THAT THEY OBTAINED THE EXPECTED O RHD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951115 ↗
• MalfunctionAug 5, 2024Computer Software Problem; Computer Software Problem

  CMS 2635536, WINDCHILL (B)(4) A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON 10 JULY 2024 TO REPORT THAT QUALITY CONTROL (QC) TESTING WAS NOT RUN AFTER A DAILY MAINTENANCE WITH THEIR ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) EQUIPPED WITH SOFTWARE VERSION 5.15.0. COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6) EVENT DATE: 25 MAY 2024. THE CUSTOMER REPORTED THAT ON 25 MAY 2024, THEY HAD PERFORMED AN ADDITIONAL DAILY MAINTENANCE AS PART OF TROUBLESHOOTING AT 4:59:16 AM, OUTSIDE OF NORMAL MAINTENANCE SCHEDULE/TIME. PER CUSTOMER'S LOCAL POLICY, QC IS REQUIRED TO BE COMPLETED ANY TIME DAILY MAINTENANCE IS PERFORMED. THE CUSTOMER STATED THAT QC WAS NOT RUN FOLLOWING THIS ADDITIONAL MAINTENANCE ON 25 MAY 2024. THE CUSTOMER STATED THAT THEY WERE NOT SATISFIED WITH THE FACT THAT THEIR ORTHO VISION ID-MTS ANALYZER ALLOWED SAMPLES TO BE RUN AND REPORTED UNTIL 3:58 PM THE SAME DAY. THE CUSTOMER REPORTED THAT ALL RESULTS OBTAINED WITH THEIR ORTHO VISION ID-MTS ANALYZER WERE ACCURATE, THUS, THE CUSTOMER CONFIRMED THAT NO PATIENT WAS HARMED BECAUSE OF THIS EVENT. THE CUSTOMER STATED THAT THE INCIDENT WAS REPORTED TO THE FDA DUE TO LOCAL QUALITY CONTROL POLICY NOT BEING FOLLOWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906349 ↗
• MalfunctionJun 27, 2024Imprecise or Erratic Results; Imprecise or Erratic Results

  (B)(4), WINDCHILL RA606616 A CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON 30 MAY 2024 TO REPORT DISCREPANT ABO-RH BLOOD GROUP FOR ONE PATIENT OBTAINED WITH THEIR ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) EQUIPPED WITH SOFTWARE VERSION 5.15.0. COMPLAINANT/COMPLAINT REPORTER NAME: (B)(6), LABORATORY TECHNOLOGIST. EVENTS DATES: 30 APRIL 2024. PATIENT INFORMATION: NO KNOWN HISTORY SAMPLE ID (B)(6) (PATIENT ID NOT DEFINED) SAMPLE ID (B)(6) (PATIENT ID (B)(6)) REDRAW SAMPLE ON (B)(6) 2024. REAGENTS: MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD (PRODUCT CODE MTS080515; LOT 012624037-11; EXPIRY DATE 08 NOVEMBER 2024) MTS DILUENT 2 PLUS (PRODUCT CODE MTS9330; LOT MDP233; EXPIRY DATE 02 OCTOBER 2024) 0.8% AFFIRMAGEN (PRODUCT CODE 719201; LOT 8A754; EXPIRY DATE 28 MAY 2024) THE CUSTOMER REPORTED THAT ON 30 APRIL 2024, THEY HAD TESTED SAMPLE ID (B)(6) FOR ABO FORWARD AND REVERSE AND D(RH1) ANTIGEN USING MTS A/B/D MONOCLONAL AND REVERSE GROUPING CARD LOT 012624037-11, MTS DILUENT 2 PLUS LOT 233 AND 0.8% AFFIRMAGEN LOT 8A754 IN COMBINATION WITH THEIR ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) AND THAT THEY HAD OBTAINED AN O D(RH1) ANTIGEN NEGATIVE RESULT. THE CUSTOMER REPORTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19626739 ↗
• MalfunctionJun 7, 2024False Positive Result; False Positive Result

  (B)(4) COMPLAINT DESCRIPTION: ON 09MAY2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT FALSE POSITIVE RESULTS FOR ONE PATIENT SAMPLE FOR ABO FORWARD GROUPING RESULTS OF THE ANTI-A COLUMN ON THEIR ORTHO VISION ID-MTS ANALYZER ((B)(6)) IN CONJUNCTION WITH MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 081623037-02. COMPLAINANT: (B)(6). DATE OF EVENT: 08DEC2023 (REPORTED 09MAY2024) EQUIPMENT: ORTHO VISION ID-MTS SERIAL (B)(6) SW VERSION: 5.15.0 (INSTALL DATE: (B)(6) 2020) REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 081623037-02, EXPIRATION DATE: 05JUN2024 0.8% AFFIRMAGEN LOT 8A676, EXPIRATION DATE: 12DEC2023 MTS DILUENT 2 PLUS LOT NOT PROVIDED. PATIENT INFORMATION: PATIENT SAMPLE ID FROM (B)(6) 2023 - (B)(6) (ENCRYPTED: (B)(6)) PATIENT'S CURRENT ABO/RH BLOOD TYPE IS O POSITIVE. (ORIGINALLY REPORTED AS A POSITIVE ON (B)(6) 2023) THE CUSTOMER REPORTED THAT ON (B)(6) 2024, THEY HAD TESTED ONE PATIENT SAMPLE FOR ABO FORWARD AND REVERSE TYPE AND RESULTS WERE DISCREPANT FROM RESULTS PRODUCED ON (B)(6) 2023. CUSTOMER REDREW THE PATIENT MULTIPLE TIMES TO VERIFY CURRENT ABO FORWARD RESULTS. PATIENT ABORH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19491170 ↗
• MalfunctionApr 10, 2024False Negative Result; False Negative Result

  (B)(4) ON 12MAR2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT MISREAD OF RESULTS BY THE CASSETTE IMAGING MANAGEMENT SYSTEM (CIMS) FOR TWO PATIENT SAMPLES FOR ABO FORWARD AND REVERSE GROUP TESTING ON THEIR ORTHO VISION ANALYZER (SERIAL#(B)(6)) IN CONJUNCTION WITH MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 102723037-08. COMPLAINANT: (B)(6). DATE OF EVENT:05MAR2024. EQUIPMENT: ORTHO VISION 50003208 SW VERSION: 5.14.5.47424. INSTALL DATE: (B)(6) 2019 REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 102723037-08, EXPIRATION DATE: 17AUG2024; 0.8% AFFIRMAGEN LOT 8A731, EXPIRATION DATE: 02APR2024. PATIENT INFORMATION: SAMPLE A SAMPLE ID: (B)(6) HISTORICAL BLOOD TYPE SAMPLE A: O. POSITIVE RESULTED ON (B)(6) 2024 AS ?POS BY ORTHO VISION SAMPLE B SAMPLE ID: (B)(6) HISTORICAL BLOOD TYPE SAMPLE B: A POSITIVE RESULTED ON (B)(6) 2024 AS O POS BY THE ORTHO VISION THE CUSTOMER REPORTED THAT ON (B)(6) 2024, THEY HAD TESTED TWO PATIENT SAMPLES FOR ABO FORWARD AND REVERSE TYPING USING MTS ABD MONOCLONAL AND REVERSE GROUPING GEL CARD LOT 102723037-08 AND 0.8% AFFIRMAGEN LOT 8A731 IN CONJUNCTION WITH THEIR ORTHO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080858 ↗
• MalfunctionApr 10, 2024False Negative Result; False Negative Result

  (B)(4), WINDCHILL (B)(4) ON (B)(6) 2024, A CUSTOMER COMPLAINED TO THE GLOBAL TECHNICAL SUPPORT CENTER (GTSC) AFTER OBTAINING WHAT WAS DESCRIBED AS DISCREPANT FALSE NEGATIVE RESULTS FOR ONE PATIENT SAMPLE FOR RHD ANTIGEN TESTING ON THEIR ORTHO VISION ANALYZER (SERIAL#(B)(6)) IN CONJUNCTION WITH MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 110923037-10. COMPLAINANT: (B)(6); LABORATORY SUPERVISOR (B)(6); (B)(6) CUSTOMER# (B)(6); LABORATORY ALLIANCE OF CENTRAL NY (B)(6) DATE OF EVENT: 04MAR2024 EQUIPMENT: ORTHO VISION 50004259 SW VERSION: 5.15.0.47622 INSTALL DATE: (B)(6)2022 REAGENTS: MTS ABD MONOCLONAL AND REVERSE GROUPING CARD LOT 110923037-10, EXPIRATION DATE: 08SEP2024 0.8% AFFIRMAGEN LOT 8A717, EXPIRATION DATE: 05MAR2024 MTS DILUENT 2 PLUS LOT MDP234, EXPIRATION DATE: 01NOV2024 PATIENT INFORMATION: PATIENT IS A PREGNANT FEMALE, APPROXIMATELY 28 WEEKS GESTATION. SAMPLE ID: (B)(6) (ENCRYPTED ID: (B)(4)) BLOOD TYPE: O POSITIVE ANTIBODY SCREEN POSITIVE, ANTI-LEA IDENTIFIED. THE CUSTOMER REPORTED THAT ON (B)(6) 2024, THEY HAD TESTED ONE PATIENT SAMPLE FOR RHD ANTIGEN USING MTS ABD MONOCLONAL AND REVERSE GROUPING GEL CARD LOT 110923037-10 IN CONJUNCTION WITH THEIR ORTHO VISION ANAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079263 ↗
• MalfunctionFeb 29, 2024Contamination; Contamination

  (B)(4) ON (B)(6) 2024, THE CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTIONS CENTER (GTSC) TO REPORT THE USE OF 0.1N SODIUM THIOSULFATE IN PLACE OF 0.1 SODIUM HYDROXIDE FOR DAILY MAINTENANCE PROCEDURE AND THE ORTHO VISION ANALYZER (SERIAL NUMBER (B)(6)) DID NOT PRODUCE A SYSTEM ERROR. COMPLAINANT: (B)(6) (MEDICAL TECHNOLOGIST) (B)(6); (B)(6); (B)(6) DATE OF EVENTS: 31JAN 2024 THROUGH 05FEB 2024, REPORTED 05FEB 2024. ORTHO VISION MTS ANALYZER (B)(6), MANUFACTURE: 09NOV2021 SOFTWARE VERSION: 5.14.5 MAINTENANCE FLUIDS: EXPECTED 0.1 SODIUM HYDROXIDE ACTUAL 0.1 SODIUM THIOSULFATE THE CUSTOMER REPORTED NO ERRONEOUS OR DISCREPANT PATIENT RESULTS WERE OBTAINED. THE CUSTOMER REPORTED THAT NO BIASED RESULT WAS REPORTED TO A PHYSICIAN. THE CUSTOMER REPORTED THAT NO PATIENT WAS HARMED AS A CONSEQUENCE OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18806508 ↗
• MalfunctionJan 17, 2024False Negative Result; False Negative Result

  CMS (B)(4), WINDCHILL RA604715 CUSTOMER CONTACTED GLOBAL TECHNICAL SOLUTION CENTER (GTSC) ON (B)(6) 2023 TO REPORT DISCREPANT NEGATIVE GRADINGS OF ANTIBODY IDENTIFICATION REACTIONS FOR ONE PATIENT OBTAINED WITH THEIR ORTHO VISION ID-MTS ANALYZER SERIAL (B)(6) EQUIPPED WITH SOFTWARE VERSION 5.14.5. COMPLAINANT NAME: (B)(6). EVENTS DATES: 20 AND 21 DECEMBER 2023. PATIENT SAMPLE ID (B)(6) REAGENTS: 0.8% SURGISCREEN, LOT VSS516 MTS ANTI-IGG CARD, LOT 061223001-10 0.8% RESOLVE PANEL A, LOTS VRA446 AND VRA448 0.8% RESOLVE PANEL B, LOT VRB317 0.8% RESOLVE PANEL C, LOT VRC318 CUSTOMER REPORTED THAT ON (B)(6) 2023, THEY TESTED SAMPLE ID (B)(6) FROM THIS PATIENT FOR ANTIBODY SCREENING IN INDIRECT ANTIGLOBULIN TEST (IAT) USING 0.8% SURGISCREEN LOT VSS516 AND MTS ANTI-IGG CARD LOT 061223001-10 IN COMBINATION WITH THEIR ORTHO VISION IDMTS ANALYZER SERIAL (B)(6) AND THAT THEY OBTAINED INDETERMINATE REACTIONS (?) WITH CELLS 1 AND 3 AND A NEGATIVE REACTION WITH CELL 2 OF THE RED CELL REAGENT. ON THE SAME DAY, THEY HAD TESTED THE SAME SAMPLE FOR ANTIBODY IDENTIFICATION IN IAT USING 0.8% RESOLVE PANEL A LOT VRA446 AND MTS ANTI-IGG CARD WITH THE SAME ANALYZER AND OBTAINED NEGATIVE REACTIONS WITH CELL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528552 ↗
• MalfunctionDec 13, 2023False Positive Result; False Positive Result

  CMS (B)(4), WINDCHILL RA604252 ON 16 NOVEMBER 2023, 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 PATIENT USING ORTHO BIOVUE SYSTEM ABO-RH/REVERSE CASSETTE LOT ABR444F IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYSER #J60002152 EQUIPPED WITH SOFTWARE VERSION 5.14.5. DATE OF EVENTS: 15 NOVEMBER 2023 AWARENESS DATE: 16 NOVEMBER 2023 COMPLAINANT/COMPLAINT REPORTER: (B)(6) REPORTED ON 16 NOVEMBER 2023 BY THE CUSTOMER TO THE GTSC. REAGENT: ORTHO BIOVUE SYSTEM ABO-RH/REVERSE CASSETTE LOT ABR444F, EXPIRY 09 JUNE 2024 PATIENT HISTORY: PATIENT KNOWN TO BE D(RH1) ANTIGEN NEGATIVE. SAMPLE ID (B)(6) THE CUSTOMER REPORTED THAT, ON (B)(6) 2023, THEY HAD TESTED A PATIENT SAMPLE (SAMPLE ID # (B)(6)) TWICE FOR D(RH1) ANTIGEN TYPING USING ORTHO BIOVUE SYSTEM ABO-RH/REVERSE CASSETTE LOT ABR444F IN CONJUNCTION WITH THEIR ORTHO VISION BIOVUE ANALYSER #J60002152, AND THAT THEY HAD OBTAINED POSITIVE REACTIONS WITH THE BIOVUE ANTI-D(RH1) REAGENT ON BOTH OCCASIONS. THE CUSTOMER STATED THAT THEY WERE EXPECTING NEGATIVE REACTIONS DUE TO THE PATIENT BEING NEGATIVE FOR D(RH1) ANTIGEN. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18316564 ↗