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	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros tsh results were obtained from samples from five different patients when tested using vitros immunodiagnostics products tsh reagent, lot 7572, on a vitros xt 7600 integrated system.The results were considered lower than expected when compared to non-vitros roche method results using the same samples.The assignable cause of the event is a specific sample interference of biotin.The customer reported that at all five patients were taking supplements containing biotin at the time of the events.As documented in the vitros tsh instructions for use (ifu), known interferences section: "specimens with biotin concentrations up to 2 ng/ml demonstrated a less than or equal to 10% change in results.Biotin concentrations greater than this falsely decrease tsh results for patient samples." based on this information, the assignable cause of the lower than expected vitros tsh results is the presence of biotin in the patient samples.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros tsh results were obtained from samples from five different patients when tested using vitros immunodiagnostics products tsh reagent, lot 7572, on a vitros xt 7600 integrated system.The results were considered lower than expected when compared to non-vitros roche method results using the same samples.Patient 1 sample 1 vitros tsh results of 0.2 uiu/ml (hyperthyroid) vs expected non-vitros result of 1.3 uiu/ml (euthyroid) patient 2 sample 1 vitros tsh results of <0.2 uiu/ml (hyperthyroid) vs expected non-vitros result of 0.70 uiu/ml (euthyroid) patient 3 sample 1 vitros tsh results of 0.18 uiu/ml (hyperthyroid) vs expected non-vitros result of 1.85 uiu/ml (euthyroid) patient 4 sample 1 vitros tsh results of 0.49 uiu/ml (euthyroid) vs expected non-vitros result of 1.53 uiu/ml (euthyroid) patient 5 sample 1 vitros tsh results of 0.28 uiu/ml (hyperthyroid) vs expected non-vitros result of 2.99 uiu/ml (euthyroid) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower-than-expected vitros tsh results were not reported from the laboratory.There was no allegation of patient harm as a result of this event.This report is number four of five mdrs for this event.Five 3500a forms are being submitted for this event as five devices were involved.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: 24687186
• Report Number: 3007111389-2026-00054
• Device Sequence Number: 15956121
• Product Code: JLW
• UDI-Device Identifier: 10758750000227
• UDI-Public: (01)10758750000227(17)260920(11)251010(10)7572
• 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): 03/25/2026

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: 09/20/2026
• Device Catalogue Number: 1912997
• Device Lot Number: 7572
• 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: 02/25/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2025
• 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