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

Model Number 6904576

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

Discrepant rhd results for two patient samples.The assignable cause was determined to be operator use error.No general product failure was identified.Biased result was reported to a physician.Corrected reports issued same day.The patients were not harmed.Customer indicated two samples were loaded in the same batch.Sample ids and sample order reports provided.(discrepant results identified by customer for sample a) sample a resulted as rhd positive, sample b resulted as rhd negative ortho care tsc reviewed sample order reports and compared to vision raw barcode scan report.It was identified in the raw barcode scan report that sample b was manually scanned and manually assigned to rack 2, position 3.While sample a was manually scanned and assigned to rack 2, position 4.However, sample a barcode was scanned by the vision internal srdr scanner and found to be in rack 2, position 3.Position 4 did not have a barcode identified by the srdr scanner.These findings corroborate that the samples were misplaced when loaded.Customer was provided with findings and referred to customer letter (cl2022-099).The customer letter further discusses the identified possible issue when utilizing ¿assign to position¿ function which will allow user to manually load samples, but if the instrument detects an alternate barcode in the assigned position, the actual barcode is not utilized, and the sample id entered using the ¿assign to position¿ function will be associated with the testing of the sample in that position.A complaint review was performed on vision max 70002037 from (b)(6) 2022through (b)(6) 2022.No additional complaints were reported for discres, falseneg, falsepos or other relevant call areas.The assignable cause is associated with user error, the customer utilized the ¿assign to position¿ function on the vision max software but placed the samples in the incorrect positions within the rack.

Event Description

This report corresponds to complaint #(b)(4) and (b)(4) customer contacted orthocare technical support to report discrepant results of one sample for rhd typing.Customer was expecting a negative reaction for one sample, as patient is d negative, but a positive reaction was obtained.Second sample had no historical result, so was not reported as discrepant.Patient information: sample a id: 10047957439 (15-88-59-36-91-ff-6c-02-a4-16-ca-b1-1a-80-ba-2c-9c-b4-2f-20-35-e5-cf-2e-e8-46-75-70-71-58-a1-59) known as rh-d negative, resulted as rhd positive.Sample b id: 10047958716 (07-7f-c6-88-86-d2-02-aa-e9-ce-ca-32-a7-27-93-53-b4-be-a6-3b-24-3a-19-62-e4-a0-20-9b-17-ff-00-2f) no patient history, resulted as rhd negative.Repeating the test on the analyzer gave a negative reaction for sample a.Additional details (include start date, frequency, observations, sample id/reagents etc.As needed): reported on 19-oct-2022 actions already performed by contact: repeated testing troubleshooting steps requested by tsc: tsc will follow up with site for details on the issue.Requesting copies of order report for investigation next action for contact: waiting for information as per order report: sample id: 10047958716 (07-7f-c6-88-86-d2-02-aa-e9-ce-ca-32-a7-27-93-53-b4-be-a6-3b-24-3a-19-62-e4-a0-20-9b-17-ff-00-2f ) was type as group o, rh negative sample id: 10047957439 (15-88-59-36-91-ff-6c-02-a4-16-ca-b1-1a-80-ba-2c-9c-b4-2f-20-35-e5-cf-2e-e8-46-75-70-71-58-a1-59)was type as group o, rh positive.As per customer, both samples were loaded on vision on 18-oct-2022 and tested as one batch but indicated that tech possible manual scan the sample and placed the sample in the incorrect position.Will review reports from vision to determine the sequence of events based on raw data report samples sample id: 10047958716 (07-7f-c6-88-86-d2-02-aa-e9-ce-ca-32-a7-27-93-53-b4-be-a6-3b-24-3a-19-62-e4-a0-20-9b-17-ff-00-2f ) was manually scan and supposed to be loaded in rack#2 and position #3 of rack.Sample id: 10047957439 (15-88-59-36-91-ff-6c-02-a4-16-ca-b1-1a-80-ba-2c-9c-b4-2f-20-35-e5-cf-2e-e8-46-75-70-71-58-a1-59) was manual scanned and should have been loaded in position #4 of the sample rack.However, as per attach report, the sample #15-88-59-36-91-ff-6c-02-a4-16-ca-b1-1a-80-ba-2c-9c-b4-2f-20-35-e5-cf-2e-e8-46-75-70-71-58-a1-59 was loaded in position #3 instead.Samples in questions were manually scanned and then the position was switched.Tsc will follow up with site and discussed the issue at occurred.Provided the raw report to customer with details on what occurred also provide copy of customer letter (cl2022-099) that further discussed this problem.Customer satisfied with explanation.Expects no further action from tsc.

• Brand Name: ORTHO VISION MAX ANALYZER GEL
• Type of Device: 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 15800919
• MDR Text Key: 308013845
• Report Number: 0002250051-2022-00600
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10758750012824
• UDI-Public: 10758750012824
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6904576
• Device Catalogue Number: 6904576
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1