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

Catalog Number	8892382
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros crbm result was obtained from a single level of non-vitros biorad multiqual unassayed controls, lot 56720 tested on a vitros 5600 integrated system.The assignable cause of the event could not be determined.Pre-analytical sample mix-up is a potential cause of the event.Three biorad level 1 results were obtained using the calibration curve from which the higher than expected vitros crbm result of 7.42 ug/ml was obtained, and two of the three results were lower than expected.The customer stated pre-analytical sample mix-up did not occur, however, provided no evidence as to why it did not occur.Acceptable vitros crbm results were obtained using two different calibration events using slide lot 3914-0123-6585 without performing any actions to optimize vitros crbm performance, therefore, a slide-related performance issue did not likely contribute to the event.No diagnostic within-run precision testing was performed to assess the performance of the vitros 5600 integrated system, however, since acceptable vitros crbm performance was obtained using two different calibration events, an instrument related performance issue did not likely contribute to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros product crbm slides, lot 3914-0123-6585.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros crbm result was obtained from a single level of non-vitros biorad multiqual unassayed controls, lot 56720 tested on a vitros 5600 integrated system.Biorad lot 56720 level 1 crbm result of 7.42 ug/ml vs.The expected result of 3.75 ug/ml 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 crbm result was obtained from a non-patient quality control fluid, however, the investigation could not rule out that patient samples would be affected if the event were to recur undetected.There was no reported allegations 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 CRBM 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: 18855595
• Report Number: 1319809-2024-00029
• Device Sequence Number: 14287327
• Product Code: KLT
• UDI-Device Identifier: 10758750005185
• UDI-Public: 10758750005185
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2024

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: 06/15/2024
• Device Catalogue Number: 8892382
• Device Lot Number: 3914-0123-6585
• 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: 02/08/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown