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	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation details: the customer stated that between (b)(6) 2024 all daily quality controls for both reagents and mts gel cards were acceptable and no patient test results were impacted.Gtsc reviewed issue with second level support team.0.1 n sodium thiosulfate is not an approved fluid for use in daily maintenance task and has not been tested for use on the analyzer, therefore any outcome, if any, is unknown on maintenance washing task or test results.The daily maintenance process includes the fluid being aspirated into the probe and probe tubing and then being dispensed and flushed out.Gtsc recommended discontinuation of use of 0.1n sodium thiosulfate for maintenance and to perform a monthly maintenance task to decontaminate the fluidic system.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 0.1n sodium thiosulfate for daily maintenance task.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 the reported event.
Event or Problem Description
(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.

• 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: 18806508
• Report Number: 2250051-2024-00006
• Device Sequence Number: 12586476
• Product Code: KSZ
• UDI-Device Identifier: 10758750012817
• UDI-Public: 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2024

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: 02/05/2024
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown