MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS 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 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected amon results were obtained when a patient sample was tested using vitros amon lot 1018-0255-3934 on a vitros 350 chemistry system.A definitive cause of the higher than expected vitros amon results was not established with the information provided.A vitros amon lot 1018-0255-3934 slide issue cannot be ruled out as a contributor to the event, as no historical qc results were provided to verify the performance of the vitros amon lot 1018-0255-3934 slides.However, qc results on the date of the event were within acceptable guidelines and ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon lot 1018-0255-3934.An instrument issue cannot be ruled out as a contributor to the higher than expected results, as no within run diagnostic precision testing was conducted when requested.The customer indicated the patient sample was not hemolyzed, therefore, hemolysis in the patient sample is an unlikely contributor to the higher than expected results.Patient sample mix up cannot be ruled out as a contributor to the event as it could not be determined whether patient sample mix up had occurred for the event.(b)(6).

Event Description

The investigation determined that higher than expected ammonia (amon) results were obtained when a patient sample was tested using vitros amon lot 1018-0255-3934 on a vitros 350 chemistry system.Vitros amon results of 101.1 and 142.7 umol/l versus the expected result of 62.8 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 not reported from the laboratory.Ortho was not made aware of any allegation of patient harm as a result of this event.This report is number one 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) (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: 12253319
• MDR Text Key: 282122958
• Report Number: 1319809-2021-00123
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0255-3934
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1