MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS AMON SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number 1726926

Device Problem High Test Results (2457)

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

Event Date 10/30/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros ammonia (amon) results were obtained when processing mas alcohol/ammonia control level 2, lot aa24011 on a vitros 5600 and vitros xt7600 system.Vitros 5600 system (s/n (b)(6) mas alcohol/ammonia control level 2, lot aa24012 vitros amon results 238.1, 239.2, 231.7, 213.7 and 210.1 umol/l versus baseline mean 167.0 umol/l vitros xt7600 system (s/n (b)(6) mas alcohol/ammonia control level 2, lot aa24012 vitros amon result 209.5 umol/l versus baseline mean 167.0 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros amon results were obtained when processing quality control fluids.There was no report of affected patient samples.There was no allegation of patient harm as a result of this event.This report is number six of six mdr¿s for this event.Six 3500a forms are being submitted for this event as six devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation concludes that higher than expected vitros ammonia (amon) results were obtained when processing mas alcohol/ammonia control level 2, lot aa24011 on a vitros 5600 and vitros xt7600 system.The definitive assignable cause of the event is unknown.An unknown quality control fluid handling issue could not be ruled out as the cause of the higher-than-expected vitros amon results.Historical vitros amon quality control results verify the performance of vitros amon slide lot 1019-0263-9013 in combination with both the vitros 5600 and the vitros xt76cfg1`00 systems leading up to the event.Additionally, acceptable vitros amon results were obtained with the same calibration curve and the same vitros amon slide cartridge.However, the customer did not process within-run precision testing on either analyzer, and did not process any vitros liquid performance verifier fluids; therefore, an issue with the vitros 5600 and vitros xt7600 systems and the vitros amon assay could not be fully ruled out as contributors to the event.Continual tracking and trending does not indicate a systemic issue with vitros amon lot 1019-0263-9013.

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18220870
• MDR Text Key: 329160548
• Report Number: 0001319809-2023-00177
• Device Sequence Number: 1
• Product Code: JID
• UDI-Device Identifier: 10758750000012
• UDI-Public: 10758750000012
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1726926
• Device Lot Number: 1019-0263-9013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1