MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. ORTHO VISION ANALYZER GEL; AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM

Catalog Number	6904577
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Windchill ra609403 the customer reported that on (b)(6) 2025, they began obtaining flagged results on multiple patient samples tested for antibody screen on their ortho vision id-mts analyzer (b)(6); analyzer 1).The same day, the customer reported that as part of troubleshooting the flagging, they checked the expiration date of the saline used on the vision.The operator discovered that the container on the analyzer was 10% formalin solution instead of buffered saline.The same day, the customer was also testing on a second analyzer, ortho vision id-mts (b)(6); analyzer 2) and identified that 10% formalin solution was also used on this analyzer instead of buffered saline.The operator immediately stopped testing on both analyzers and replaced liquid bottles with the correct reagents.Weekly and daily maintenance were performed, new sets of reagent red cells were opened, and qc was run successfully on both analyzers.The customer reported patient samples tested on analyzer 1 while 10% formalin was on board, were retested the same day.Three samples which were originally reported with positive antibody screens were confirmed upon retest.No additional details were provided.The same day, the customer reported that samples tested on analyzer 2 while 10% formalin was on board, were also repeated.The customer stated these samples had originally produced negative results for antibody screens, and the results remained negative upon retest.Gtsc reviewed with the customer that the ortho vision id-mts analyzer is not validated with any other fluids than di water and saline.The customer had performed all necessary troubleshooting steps.No further investigation was performed on this incident.The assignable cause is user error, associated with the operator accidently utilizing 10% formalin solution in place of buffered saline.There was no evidence of any systematic failure of the ortho clinical diagnostics analyzers to perform as intended.No general failure of the ortho vision analyzers has been identified.No further complaints of this type have been received from the customer site since the time of the reported event.

• Brand Name: ORTHO VISION ANALYZER GEL
• Common Device Name: AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21717964
• Report Number: 2250051-2025-00018
• Device Sequence Number: 4514849
• Product Code: KSZ
• UDI-Device Identifier: 10758750012817
• UDI-Public: (01)10758750012817
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6904577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown