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

Catalog Number	6802584
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a non-reproducible higher than expected vitros creatinine (crea) result was obtained from a single patient sample tested on a vitros 5600 integrated system.The most likely assignable cause of the event is unknown.A sample related issue cannot be completely ruled out as the customer was not following the sample collection device manufacturer recommendations for sample centrifugation.It is likely that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.It is possible that pre-analytical sample mix-up was the cause of the event.The indices for each test event were reviewed from e-connectivity and the indices were below the cutoffs for both test events.In addition, the sample viscosity for both test events were identical.Therefore, it was not possible to confirm or rule out that pre-analytical sample mix-up occurred.Historic vitros crea quality control results were acceptable within the timeframe of the event, indicating that vitros crea slide lot 1515-3572-0682 was performing as intended on the vitros 5600 integrated system.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros crea slide lot 1515-3572-0682.A performance issue with the vitros 5600 system did not likely contribute to the event as a diagnostic vitros alkp diagnostic within-run precision test was within-in acceptance criteria.The vitros alkp diagnostic within-run precision test is used to assess performance of the vitros 5600 integrated system.Therefore, an instrument related performance issue did not likely contribute to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible higher than expected vitros creatinine (crea) result was obtained from a single patient sample tested on a vitros 5600 integrated system.Patient sample vitros crea result of 12 mg/dl vs.The expected result of 0.90 mg/dl 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 crea result was not reported outside of the laboratory and 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 CREA 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24500707
• Report Number: 1319809-2026-00015
• Device Sequence Number: 9943201
• Product Code: JFY
• UDI-Device Identifier: 10758750002849
• UDI-Public: (01)10758750002849(17)260701(11)250131(10)151535720682
• 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): 03/02/2026

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: 07/01/2026
• Device Catalogue Number: 6802584
• Device Lot Number: 1515-3572-0682
• 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: 02/03/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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