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

Catalog Number	6904577
Medical Device Problem Codes	Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Investigation details: the customer stated that following maintenance activities on (b)(6) 2024 at approximately 21:00pm, the operator noted a large number of positive antibody screen results, that were producing negative results when repeated in manual gel method using the same lots of reagent red cells and mts gel cards.The customer further inspected the ortho vision id-mts analyzer and identified the saline wash bottle was filled with 10% formalin solution.The operator immediately notified the site supervisor, and all previously tested samples were re-tested at a sister facility.All aborh re-test results matched the results obtained on the ortho vision id-mts analyzer with 10% formalin used.All antibody screen re-test results produced no clinically significant antibodies.The customer concluded from the re-testing at a sister facility that no erroneous results had been reported as a result of this event.Gtsc reviewed with the customer that the ortho vision id-mts analyzer is not validated with any other fluids than water and saline.The customer was advised to empty the saline container, flush thoroughly with di water, fill with appropriate liquids, and repeat the weekly decontamination three times to thoroughly flush all lines and run quality control testing.On (b)(6) 2024, the customer determined that although decontamination was performed as advised and quality control testing was acceptable, the site would not use the analyzer until an ortho field engineer inspected the analyzer fully.On 04sep2024, an ortho field engineer went on-site to replace all tubing, flow sensors and the fawa pump, and to clean the wash station and wash bottle fitting.All post-requisite testing and quality control testing was performed successfully, and the ortho vision id-mts analyzer was returned to service.Customer stated no patient sample results were affected by this event.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 analyzer to perform as intended.No general failure of the ortho vision id-mts analyzer 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: 20321956
• Report Number: 2250051-2024-00036
• Device Sequence Number: 7630573
• Product Code: KSZ
• UDI-Device Identifier: 10758750012817
• UDI-Public: (01)10758750012817(11)210720
• 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): 09/20/2024

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: 08/31/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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