MAUDE Adverse Event Report: ORTHO VISION MAX ANALYZER GEL; AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM

Model Number	6904576
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Results on the ortho vision max id-mts analyser software appear in an abnormal colour scheme with condition code flags in multiple columns.The most probable assignable cause is analyser related, when an error occurs between the camera and/or camera software and cims, the image queues can contain 1-2 images more than the count expected by cims software.If images remain in the queues from a previous operation, they will be used first, instead of the intended/appropriate image.The result was rejected by the analyser.No biased result was reported to physician.No patient was harmed.
Additional Manufacturer Narrative
Ortho investigation: during normal operation of the ortho vision analyzer, the camera imaging subsystem (cims) interfaces with a hardware camera to request and retrieve camera images for column grading and results interpretation.The camera software uses a first-in, first-out queuing system to take and return images to the cims software.Under an atypical software anomaly, a customer observed that images used for analysis of a test result did not come from the front and back sides of the same card.Ortho determined that the cims processed images out of synchronization (images captured earliest in sequence are placed at the top of the queue to be processed).As a result, image processing software utilized on the ortho vision analyzer may use mismatched front of card and back of card images for column grading and result interpretation.The most probable assignable cause is analyzer-related, when an error occurs between the camera and/or camera software and cims, the image queues can contain 1-2 images more than the count expected by cims software.If images remain in the queues from a previous operation, they will be used first, instead of the intended/appropriate image.A communication (cl2022-243) was sent on (b)(6) 2022 and advised customers that until a software update is available, when the ortho vision analyzer posts a cims28, cims33, cims35, or a cims02 error code, to please abort all tests in-process, shut down the system and restart the analyzer.Restarting the analyzer will reset the software and resynchronize camera images to resolve the use of mismatched images.In addition, results generated around the time the error code was reported should be reviewed for concordance with known patient information, if available.The fda was notified of this issue on (b)(6) 2022.Us fda recall report number: (b)(4).

• Brand Name: ORTHO VISION MAX ANALYZER GEL
• Common Device Name: AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
• Manufacturer Contact: o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16004117
• Report Number: 0002250051-2022-00612
• Device Sequence Number: 5784331
• Product Code: KSZ
• UDI-Device Identifier: 10758750012824
• UDI-Public: 10758750012824
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/16/2022

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 Model Number: 6904576
• Device Catalogue Number: 6904576
• 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: 11/26/2022
• Initial Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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