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

Catalog Number	8221384
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros phenobarbital (phbr) results were obtained from a single american proficiency institute (api) proficiency survey sample when processed using vitros phbr slide lots 2517-0117-7418 and 2517-0117-7396 on a vitros xt 7600 integrated system.Vitros phbr lot 2517-0117-7396 (lot 1): initial api proficiency sample vitros phbr result of 46.0 ug/ml vs.The api peer target of 62.3 ug/ml vitros phbr lot 2517-0117-7418 (lot 2): initial api proficiency sample vitros phbr results of 46.6, 49.0 ug/ml vs.The api peer target of 62.3 ug/ml new api proficiency sample vitros phbr result of 42.4 ug/ml vs.The api peer target of 62.3 ug/ml biased results of the magnitude and direction observed may led to inappropriate physician action if they were to occur undetected on patient samples.The lower-than-expected vitros phbr results were obtained from a non-patient proficiency sample.There was no allegation of patient harm as a result of this event.This report is number one of four mdrs for this event.Four 3500a forms are being submitted for this event as four devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(6).
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros phenobarbital (phbr) results were obtained from a single american proficiency institute (api) proficiency survey sample when processed using vitros phbr slide lots 2517-0117-7418 and 2517-0117-7396 on a vitros xt 7600 integrated system.The assignable cause of the event could not be determined with the information provided.Historical vitros phbr lot 1 and lot 2 qc results showed some inaccuracy and imprecision, therefore an issue with either of these lots cannot be ruled out as a potential contributor to the event.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phbr slide lots 2517-0117-7418 and 2517-0117-7396.An instrument-related performance issue cannot be ruled out as contributor to the event, as no diagnostic precision testing was performed to assess instrument performance.Therefore, an issue with the vitros xt 7600 integrated system cannot be confirmed or ruled out as a contributor to the event.Additional troubleshooting including processing calibrator fluids as patients, and a patient comparison between vitros phbr calibrations and lots was requested from the customer, however this has not been completed at the time of this report.Although the calibrations in use at the time the vitros phbr repeat results were obtained showed some atypical parameters, the qc imprecision observed by the customer would not be affected by calibration.As the customer is observing both inaccuracy with their l3 fluid and imprecision on both levels, it is possible that a suboptimal calibration could contribute to inaccurate results, while the cause of the imprecision could be from another factor.However, this could not be confirmed at this time with the information provided.

• Brand Name: VITROS CHEMISTRY PRODUCTS PHBR 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: 24746592
• Report Number: 1319809-2026-00031
• Device Sequence Number: 9166106
• Product Code: DLZ
• UDI-Device Identifier: 10758750004560
• UDI-Public: (01)10758750004560(17)260901(11)250901(10)251701177418
• 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): 03/31/2026

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: 09/01/2026
• Device Catalogue Number: 8221384
• Device Lot Number: 2517-0117-7418
• 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: 03/05/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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