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	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concluded that a higher-than-expected result was obtained from a single level of non-vitros biorad ethanol/ammonia control, lot 54420, using vitros ammonia (amon) slide lot: 1019-0266-4652 on a vitros xt 7600 integrated system.The assignable cause of the event was unable to be determined.Historical vitros amon qc was within expectation leading up to the event, indicating that vitros amon lot: 1019-0266-4652 was performing as expected in combination with the vitros xt7600 system.Additionally, within-run precision testing using vitros amon and vitros alkp were within ortho acceptable guidelines, further indicating that vitros amon was performing as expected and that the vitros xt7600 was not a likely contributor to the event.Continual tracking and trending does not indicate a systemic issue with vitros amon lot: 1019-0266-4652.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher-than-expected result was obtained from a single level of non-vitros biorad ethanol/ammonia control, lot: 54420, using vitros ammonia (amon) slide lot: 1019-0266-4652 on a vitros xt 7600 integrated system.Biorad level 2 amon results of 111.3? mol/l versus the expected result of 91.2? mol/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 customer did not process any patient samples while the quality control results were outside expectation, 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).

• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20619586
• Report Number: 1319809-2024-00084
• Device Sequence Number: 7354334
• Product Code: JID
• UDI-Device Identifier: 10758750000012
• UDI-Public: (01)10758750000012(17)260101(11)240725(10)101902664652
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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: 01/01/2026
• Device Catalogue Number: 1726926
• Device Lot Number: 1019-0266-4652
• 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: 10/09/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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