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	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected thyroid stimulating hormone (tsh) results were obtained from american proficiency institute (api) proficiency sample fluids using vitros immunodiagnostic products tsh reagent lot 7540 on a vitros 5600 integrated system.An assignable cause of the event could not be determined.Based on historical quality control results a vitros tsh reagent lot 7540 related issue is not a likely contributing factor of the event.Furthermore, continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lot 7540.As no precision testing was performed on the vitros 5600 system around the time of the event, an instrument related issue cannot be entirely ruled out as a contributing factor of the event.However, there was no evidence indicating an instrument malfunction as quality control results were within expectations and acceptable results were obtained on the instrument for the other api samples at the time of the event.The customer stated that the proficiency samples were prepared, handled and stored according to the protocol recommended by api.However, an issue related to samples ch-01 and ch-02 cannot be ruled out as acceptable results were obtained using the other proficiency samples.Additionally, customer result for sample ch-02 breached potential health and safety criteria when compared to the mean value, however, was determined to be acceptable by api.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected thyroid stimulating hormone (tsh) results obtained from american proficiency institute (api) proficiency sample fluids using vitros immunodiagnostic products tsh reagent lot 7540 on a vitros 5600 integrated system.Api sample ch-01 vitros tsh result of 1.82 uiu/ml vs an expected result of 3.423 uiu/ml api sample ch-02 vitros tsh result of <0.02 uiu/ml vs an expected result of 0.062 uiu/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 lower than expected vitros tsh results were from non-patient fluids.There were no 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 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: 25283754
• Report Number: 3007111389-2026-00106
• Device Sequence Number: 9968342
• Product Code: JLW
• UDI-Device Identifier: 10758750000227
• UDI-Public: (01)10758750000227(17)260702(11)250723(10)7540
• 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): 05/26/2026

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: 07/02/2026
• Device Catalogue Number: 1912997
• Device Lot Number: 7540
• 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: 03/10/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• 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