MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS 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 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected vitros ammonia (amon) result was obtained from a patient sample and that lower than expected results were obtained from a quality control fluid using vitros chemistry products amon slides on a vitros 350 chemistry system.The assignable cause of the unexpected, imprecise vitros amon results could not be determined, however, an instrument issue related to incubator contamination in combination with a mechanical issue cannot be ruled out.Prior to service actions performed by an ortho field engineer, the customer observed imprecision using two different vitros amon reagent lots, however a within-run vitros amon precision test performed by the customer produced acceptable results.The customer continued to observe imprecision on their l2 quality control fluid across two lots of vitros amon, indicating the vitros 350 chemistry system was not performing as intended in combination with vitros amon.The ortho field engineer performed service actions on the vitros 350 chemistry system which included cleaning the microslide incubator to remove incubator contamination, replacing the evaporation caps, cleaning the sample metering proboscis, and performing microslide incubator adjustments.The ortho field engineer indicated that the vitros 350 chemistry system was performing as expected following the service actions, and the customer reported no additional issues with their vitros amon.However, no post service qc data or precision was provided, therefore it can't be confirmed that the service actions by the ortho fe returned the vitros 350 system to acceptable performance.Continual tracking and trending does not indicate a systemic issue with vitros amon lot 1018-0255-7830.(b)(4).

Event Description

The investigation determined that a lower than expected vitros ammonia (amon) result was obtained from a quality control fluid using vitros chemistry products amon slides on a vitros 350 chemistry system.Vitros lpv level 2 results of 118.4 and 139.3 umol/l versus the expected result of 174.8 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros amon result was obtained from a patient sample and the lower than expected results were obtained from a non-patient quality control fluid.There was no reported allegation of patient harm as a result of this event.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 (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: 12656075
• MDR Text Key: 282103781
• Report Number: 1319809-2021-00151
• 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: health professional
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0255-7830
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1