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 Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros amon results were obtained from non-vitros biorad quality control (qc) fluids and from vitros liquid performance verifiers (lpv) using vitros chemistry products amon slides lot 1018-0252-1920 on a vitros 5600 integrated system.The investigation was unable to determine a definitive assignable cause.Calibration variability is a possible cause of the event as the qc results were higher than expected after the calibration event of (b)(6) 2020 and then were within expectations after the calibration from (b)(6) 2020 without any other apparent troubleshooting taking place.However, the data from both calibrations was similar overall.No further testing was conducted using the calibration from (b)(6) 2020; therefore, a calibration to calibration variability issue could not be confirmed nor ruled out.It is unknown if the customer tested the vitros pv fluids after the calibration event of (b)(6) 2020.Therefore, the no results could be compared to the higher than expected results obtained using the calibration event from (b)(6) 2020.Historical quality control results were not available for vitros amon lot 1018-0252-1920 as it was a new lot of reagent at the time of the event.Therefore, an issue with vitros amon lot 1018-0252-1920 could not be entirely ruled out as contributing to the event.However, qc results after the calibration event of (b)(6) 2020 were within expectations and the customer appears to have put lot 1018-0252-1920 into routine use.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros amon lot 1018-0252-1920.Precision testing was not completed on the vitros 5600 integrated system.Therefore, an issue with the vitros 5600 integrated system cannot be entirely ruled out as a contributor to the event.However, there was no evidence to suggest that the vitros 5600 integrated system malfunctioned.No information regarding fluid preparation and handling was provided by the customer.Therefore, an issue related to pre-analytical sample pv fluid preparation and handling cannot be ruled out as a contributor of the event.

Event Description

On (b)(6) 2020 a customer contacted the ortho clinical diagnostics technical service center (tsc) to report higher than expected results obtained from non-vitros biorad quality control (qc) fluids and vitros liquid performance verifier (lpv) fluids using vitros chemistry products amon slides on a vitros 5600 integrated system.Vitros lpv ii lot j6667 vitros amon result of 229* umol/l vs.An expected result of 186.9 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 results were from qc fluids and were not reported outside of the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (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
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9706383
• MDR Text Key: 214634735
• Report Number: 1319809-2020-00012
• Device Sequence Number: 1
• Product Code: JID
• 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
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0252-1920
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1