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	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation details: the customer stated that following weekly maintenance activities, the operator noted all dat and antibody screen testing was producing positive results; however, negative results were obtained when repeated in manual gel method using the same lots of reagent red cells and mts gel cards.The customer opened a new set of red cell reagents and diluents and performed quality control (qc) testing.Qc was acceptable; however, upon re-testing the samples on the ortho vision id-mts analyzer, the results were all continued to produce positive results.As part of troubleshooting with the customer, gtsc requested that the operator check the liquids on the ortho vision id-mts analyzer, and it was identified that the saline wash bottle was filled with methanol solution.Gtsc instructed customer to perform weekly maintenance with correct fluids, daily maintenance and repeat qc.The following day, on (b)(6) 2024, the customer reported that patient samples continue to produce false positive reactions for antibody screen testing and requested field service to address issue.On (b)(6) 2024, ortho field service engineer (fse) visited the site and replaced all fluidic components of the ortho vision including flow sensors, two-way valve, fawa pump, connectors, wash bottles, probe and all tubing.The same day the customer performed maintenance and qc testing successfully.Patient samples were tested and produced positive results.The fse identified at that time that the customer had utilized formalin in place of saline in the wash bottle again contaminating the analyzer.Additional service is needed to again replacement all fluidic components.Fse required additional parts to complete.This service is expected to resolve the issue.The customer stated no erroneous results were reported.No further investigation was performed on these incidents.The assignable cause is user error, associated with the operator accidently utilizing methanol and formalin solutions 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 analyzer has been identified.No further complaints of this type have been received from the customer site since the time of these reported events.
Event or Problem Description
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.

• 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: 20795253
• Report Number: 2250051-2024-00042
• Device Sequence Number: 7809113
• Product Code: KSZ
• UDI-Device Identifier: 10758750012817
• UDI-Public: (01)10758750012817(11)201012
• 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): 11/27/2024

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: 11/07/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2020
• 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