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

Catalog Number	1721869
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The investigation determined that a lower than expected vitros ammonia (amon) result was obtained from a cap proficiency fluid processed using vitros chemistry products amon slides lot 1020-0265-9321 on a vitros xt 7600 integrated system.Chm-07 amon result of 101 umol/l versus an expected result of 181 umol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if the results were to recur undetected.The lower than expected vitros amon result was generated from a non-patient fluid; however, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There were no allegations of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment ra607130.
Additional Manufacturer Narrative
The investigation determined that a lower than expected vitros ammonia (amon) result was obtained from a cap proficiency fluid processed using vitros chemistry products amon slides lot 1020-0265-9321 on a vitros xt 7600 integrated system.The assignable cause of the event was not able to be determined.A review of historical amon quality control results indicated unacceptable within laboratory precision.Therefore, a vitros amon lot 1020-0265-9321 issue cannot be ruled out as a contributor of the event.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros amon reagent lot 1020-0265-9321.As no precision testing was performed on the vitros xt 7600 system around the time of the event, an instrument related issue cannot be ruled out as a potential contributing factor of the event.The customer reported that a result obtained from the same chm-07 cap fluid for an alternate vitros assay (tbil) was unacceptable as well.Therefore, a sample related issue cannot be ruled out as a contributor of the event.

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON SLIDES
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC ROCHESTER; 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20089067
• Report Number: 1319809-2024-00062
• Device Sequence Number: 7661672
• Product Code: JID
• UDI-Device Identifier: 10758750009602
• UDI-Public: (01)10758750009602(17)250801(11)240201(10)102002659321
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/28/2024

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: 08/01/2025
• Device Catalogue Number: 1721869
• Device Lot Number: 1020-0265-9321
• 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: 08/01/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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