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

Catalog Number 1726926

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 04/29/2021

Event Type  malfunction  

Event Description

The investigation determined that lower and higher than expected vitros ammonia (amon) results were obtained from a vitros liquid performance verifier (lpv) control fluid processed using vitros chemistry products amon slides lot 1018-0254-3413 and lot 1018-0255-4014 on a vitros 250 chemistry system. Vitros amon lot 1018-0254-3413: vitros lpv ii lot q8086 results of 148. 0 and 153. 0 umol/l vs an expected result of 193. 7 umol/l vitros amon lot 1018-0255-4014: vitros lpv ii lot q8086 results of 152. 0 and 247. 0 umol/l vs an expected result of 193. 7 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 lower and higher than expected vitros amon results were obtained when processing a control fluid. No results were reported out of the laboratory. There was no reported allegation of patient harm as a result of this event. This report is number three of four mdr¿s for this event. Four 3500a forms are being submitted for this event as four devices were involved. This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

Manufacturer Narrative

A definitive assignable cause could not be determined based on the information provided. Based on historical quality control results, a vitros amon reagent issue cannot be ruled out as a potential contributing factor of the event. However, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon reagent lot 1018-0254-3413 or 1018-0255-4014. An instrument related issue cannot be ruled out as contributor of the event as historical qc results were imprecise using both vitros amon reagent lots. Additionally, no precision testing was performed on the vitros 250 system to verify instrument performance. The customer elected not to troubleshoot the issue further as they will be converting from a vitros 250 chemistry system to a vitros 4600 chemistry system. The customer decided to suspend vitros amon processing until the vitros 4600 system has been implemented. Email address for contact office is (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 12668570
• MDR Text Key: 282048278
• Report Number: 1319809-2021-00154
• Device Sequence Number: 1
• Product Code: JID
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0255-4014
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No