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

Catalog Number	1912997
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected tsh results were obtained from a single patient sample tested using vitros immunodiagnostics products tsh reagent, lots 7530 and 7560, on two different vitros xt 7600 integrated systems.The results were considered discordant when compared to another result obtained from a second sample from the same patient, tested on a different vitros xt 7600 integrated system at an alternate customer site.Vitros xt 7600 integrated system: s/n (b)(6) (j1): sample 2, vitros tsh lot 7530 results of 5.64 uiu/ml (hypothyroid) vs.The expected result of 2.66 uiu/ml (euthyroid).Vitros xt 7600 integrated system: s/n (b)(6) (j2): sample 2, vitros tsh lot 7530 result of 5.58 uiu/ml (hypothyroid) vs.The expected result of 2.66 uiu/ml (euthyroid).Vitros xt 7600 integrated system: s/n (b)(6) (j2): sample 2, vitros tsh lot 7560 result of 5.63 uiu/ml (hypothyroid) vs.The expected result of 2.66 uiu/ml (euthyroid).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 tsh results were reported from the laboratory.However, a physician questioned the results and no treatment was initiated, altered, or stopped based on the reported result and a corrected report of 2.66 uiu/ml was later issued for the patient.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number three of three mdrs for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment 613158.
Additional Manufacturer Narrative
The investigation determined higher than expected tsh results were obtained from a single patient sample tested using vitros immunodiagnostics products tsh reagent, lots 7530 and 7560, on two different vitros xt 7600 integrated systems.The results were considered discordant when compared to another result obtained from a second sample from the same patient, tested on a different vitros xt 7600 integrated system at an alternate customer site.The assignable cause of the event could not be determined with the information provided.A vitros tsh lot 7530 and 7560 reagent related issue is not a likely contributor to the event as historical qc fluid results were accurate and precise.Additionally, ongoing tracking and trending does not indicate any performance concerns with these lots.In addition, pre-analytical sample processing cannot be ruled out as a contributing factor, as the customer was not following the sample collection device manufacturers recommendations for centrifugation.Cellular debris, possibly resulting from inadequate sample preparation, may have been present in the affected sample; however, this could not be confirmed.A vitros tsh within-run precision study performed on instrument j1 was within orthos acceptable guidelines, indicating that an instrument issue was not a likely contributor to the event.As no precision testing was performed on instrument j2, its performance at the time of the event could not be confirmed.While unexpected instrument issues cannot be completely ruled out, the customer reported no signs of malfunction, and repeatable results for the sample were obtained using two different lots of vitros tsh reagent on the instrument making it unlikely that j2 contributed to the event.The patient was described as having chest pain, headache, hypertension, and anxiety disorder, and is on long-term drug therapy.Current medications include alprazolam (0.25 mg daily), atorvastatin (40 mg daily), epinephrine (0.3 mg), hydroxyzine hcl (25 mg daily), iosartan (25 mg daily), and paxil (10 mg as needed).A sample related issue for the second sample of the patient due to interference cannot be entirely ruled out as a contributor of the events.Per the vitros tsh instructions for use: "certain drugs and clinical conditions are known to alter tsh concentrations in vivo." no additional thyroid marker testing was performed.Tests conducted: comprehensive metabolic panel (cmp), complete blood count (cbc), troponin, creatine kinase (ck), and interference testing for hemolysis, icterus, and lipemia.A medical consultation was requested from an ortho medical safety advisor (msa) who reported that: "a patient had discordant vitros tsh results when samples were analyzed on two different vitros instruments using different reagent lots.The second tsh result, obtained four days after an initial euthyroid result, was in the hypothyroid range.Although the hypothyroid result was reported from the laboratory, there was no inappropriate physician intervention.Tsh is a primary biochemical marker for evaluating thyroid function and is routinely used for screening, diagnostic assessment, and treatment monitoring.When an abnormal tsh result is obtained, further tests such as thyroid hormone levels (free t4, free t3, and total t3) are typically performed to further characterize the thyroid disorder.In this case, the higher-than-expected repeat result prompted further testing, resulting in the detectability of the erroneous result.Additionally, no treatment was initiated or altered as a result of the erroneous result, and no patient harm was reported.Based on the overall clinical course, there is no anticipated patient risk with this product issue.".

• 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: 24123263
• Report Number: 3007111389-2026-00008
• Device Sequence Number: 14971546
• Product Code: JLW
• UDI-Device Identifier: 10758750000227
• UDI-Public: (01)10758750000227(17)260630(11)250715(10)7530
• 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): 01/20/2026

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: 06/30/2026
• Device Catalogue Number: 1912997
• Device Lot Number: 7530
• 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: 12/23/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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