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

Catalog Number 1726926

Device Problem Low Test Results (2458)

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

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros ammonia (amon) results were recovered from the calibrator level 2 from calibrator kit lot 0522, tested on a vitros xt7600 integrated system.The assignable cause of the event could not be determined with the information provided.A performance issue with the calibrator 0522 level 2 fluid on site cannot be ruled out as contributing to the event.The calibrator 0522 level 1 and level 3 results were acceptable, and acceptable vitros amon performance was obtained using an alternate vitros calibrator kit 5, lot 0532.Historic quality control results obtained from vitros amon slide lot 1020-0262-5572 was acceptable, indicating vitros amon slide lot 1020-0262-5572 was performing as intended within the timeframe of the event and did not likely contribute to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros amon slide lot 1020-0262-5572.The customer made no indication of a performance issue with the vitros xt7600 integrated system during the timeframe of the event, however, as no diagnostic within-run precision testing used to assess the performance of the vitros instrument was performed, a performance issue with the vitros xt7600 integrated system cannot be completely ruled out as contributing to the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros ammonia (amon) results were recovered from the calibrator level 2 from calibrator kit lot 0522, tested on a vitros xt7600 integrated system.Vitros amon calibrator level 2 results of 39 and 32 umol/l vs.The expected result of 102 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.There was no report of affected patient results and there was no allegation of patient harm.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 602732.

• 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: 17510429
• MDR Text Key: 320890070
• Report Number: 0001319809-2023-00071
• 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: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: 1726926
• Device Lot Number: 1020-0262-5572
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1