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

Catalog Number	8433880
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concludes that a higher than expected vitros lac result was obtained when processing a non-vitros biorad quality control fluid on a vitros 4600 chemistry system.The cause of the higher than expected vitros lac result is unknown.The vitros lac instructions for use section "when to calibrate" points to clia regulations which require calibration or calibration verification at least once every six months.The calibration curve in use at the time of the higher than expected vitros lac result was approaching 6 months (initial calibration on 28 july 2023).Subtle changes over time could cause quality control results to drift which can be resolved by a calibration event.A diagnostic within run precision testing was not performed on the vitros 4600 system, therefore the system cannot be entirely ruled out as a contributor of the event.Vitros lac lot 3533-0121-1237 is performing as expected in combination with the vitros 4600 system after the calibration event on 21 january 2024.Continual tracking and trending of complaints has not identified any signals that would point to potential systemic issues with vitros lac lot 3533-0121-1237.
Event or Problem Description
A customer contracted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros lac result was obtained when processing a non-vitros biorad quality control fluid on a vitros 4600 chemistry system.Biorad multiqual premium assayed controls, lot 86960, vitros lac result of 6.22 mmol/l versus the baseline mean of 4.80 mmol/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 vitros lac result was obtained when processing quality control fluids.There was no allegation 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 (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS LAC SLIDES
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; 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: 18857183
• Report Number: 1319809-2024-00030
• Device Sequence Number: 15513705
• Product Code: KHP
• UDI-Device Identifier: 10758750004911
• UDI-Public: 10758750004911
• 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): 03/07/2024

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: 11/01/2024
• Device Catalogue Number: 8433880
• Device Lot Number: 3533-0121-1237
• 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: 02/09/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown