MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	1912997
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower than expected tsh a single patient sample result was obtained when tested using the vitros immunodiagnostics products tsh reagent, lot 7590, on a vitros xt 7600 integrated system.This patient sample result was considered discordant when compared with repeat testing of the same sample.The assignable cause of the events was not determined with the information provided.Based on qc results obtained during the timeframe of the event, a reagent-related issue cannot be ruled out as a potential contributing factor.No precision testing was performed on the vitros xt 7600 integrated system at the time of the event; therefore, instrument performance could not be fully assessed, and an instrument-related issue cannot be ruled out as a potential contributor.In addition, pre-analytical sample processing cannot be excluded as a contributing factor.It was established that the customer was not following the sample collection device manufacturers centrifugation recommendations, and cellular debris due to inadequate sample preparation may have been present in the affected sample; however, this could not be confirmed.Furthermore, the time interval between the two testing events was not provided.Therefore, a patient sample mix-up or sample storage related issue cannot be ruled out as a potential contributor to the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lot 7590.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected tsh a single patient sample result was obtained when tested using the vitros immunodiagnostics products tsh reagent, lot 7590, on a vitros xt 7600 integrated system.This patient sample result was considered discordant when compared with repeat testing of the same sample.Vitros tsh patient result of <0.015 miu/l (hyperthyroid classification) vs.The expected result of 0.242 miu/l (hyperthyroid classification) the lower than expected vitros tsh result of <0.015 miu/l was not reported from the laboratory.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) and reportability assessment 613627.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
• 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; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24500220
• Report Number: 3007111389-2026-00041
• Device Sequence Number: 13247570
• Product Code: JLW
• UDI-Device Identifier: 10758750000227
• UDI-Public: (01)10758750000227(17)260921(11)251031(10)7590
• 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): 03/03/2026

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: 09/21/2026
• Device Catalogue Number: 1912997
• Device Lot Number: 7590
• 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: 02/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2025
• 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