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

Catalog Number	1726926
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a discordant, higher than expected vitros ammonia (amon) result was obtained from a patient sample using a new vitros amon slide lot tested on a xt7600 integrated system when compared to a vitros amon result obtained from the sample using the previous vitros amon slide lot tested on the same vitros 5600 integrated system.The assignable cause of the event is user error due to improper storage of the patient sample used in the correlation.The customer could not provide the collection dates or the test dates for the sample when it was tested with the previous vitros amon slide lot, but stated it was likely the sample was stored frozen for greater than 1 month.Per the vitros amon instructions for use, samples stored at =-18 °c (=0 °f) are stable for = 24 hours.The sample was stored greater than 24 hours and is therefore not appropriate for testing with the vitros amon assay.Ammonia is a time sensitive assay due to increase in ammonia concentration as the sample ages.Acceptable vitros amon performance was obtained from non-vitros biorad quality control fluids, vitros liquid performance verifier fluids and vitros calibrator fluids processed as unknown samples, indicating vitros amon slide lot 1929-0264-4179 was performing as intended on the vitros xt7600 integrated system.Therefore, it is unlikely vitros amon slide lot 1929-0264-4179 or the vitros xt7600 integrated system contributed to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a discordant, higher than expected vitros ammonia (amon) result was obtained from a patient sample using a new vitros amon slide lot tested on a xt7600 integrated system when compared to a vitros amon result obtained from the same sample using the previous vitros amon slide lot tested on the same vitros 5600 integrated system.Correlation sample 2 vitros amon result of (b)(4) vs.The expected result of (b)(4).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 obtained from the correlation sample was not reported out of the laboratory and there was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON SLIDES
• Common Device Name: 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: 18438781
• Report Number: 0001319809-2024-00001
• Device Sequence Number: 7024374
• Product Code: JID
• UDI-Device Identifier: 10758750000012
• UDI-Public: 10758750000012
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2025
• Device Catalogue Number: 1726926
• Device Lot Number: 1019-0264-4179
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2023
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown