MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS XT 7600 INTEGRATED SYSTEM; CLINICAL CHEMISTRY

Catalog Number	6844461
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected hba1c results were obtained from non-vitros biorad quality controls as well as samples from two different patients processed using vitros chemistry products hba1c reagent lot 1539-47-3424 on a vitros xt 7600 integrated system.The assignable cause of the event is user error.The customer had switched to a new lot of cuvettes and performed a water blank on the vitros xt 7600 system.Following these actions, quality control results for vitros hba1c lot 1539-47-3424 were not within expectations.According to v-docs on the vitros xt 7600 system and the vitros hba1c instructions for use, the customer should have recalibrated the vitros hba1c reagent on the instrument.However, the customer did not do so at the time of the event.A later recalibration event resolved the issue.Based on historical quality control results, a vitros hba1c lot 1539-47-3424 performance issue is not a likely contributor of the event.Additionally, an individual pack related issue was ruled out as unacceptable results were obtained using two different reagent packs and two different packs of dil 5.The ortho tsc advised the customer to reprocess any patient samples that had been tested after the cuvette lot switch and waterblank were performed and prior to the recalibration event performed on 27 february 2026.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected hba1c results obtained from non-vitros biorad quality controls as well as samples from two different patients processed using vitros chemistry products hemoglobin a1c (hba1c) reagent lot 1539-47-3424 on a vitros xt 7600 integrated system.Biorad lot 89250 l1 results of 7.36, 7.42, 7.32, 7.35 and 7.23 %a1c vs an expected result of 5.33 %a1c biorad lot 89250 l2 results of 13.15, 13.13, 13.36, 13.27 and 13.08 %a1c vs an expected result of 8.26 %a1c patient 1 result of 7.8 %a1c vs an expected result of 5.5 %a1c patient 2 result of 8.6 %a1c vs an expected result of 6.0 %a1c biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected results were obtained from control fluids and were not reported out of the laboratory.The customer did not process patient samples after the higher than expected quality control results were obtained other than for troubleshooting purposes and the results were not released from the laboratory.There have been 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 613848.

• Brand Name: VITROS XT 7600 INTEGRATED SYSTEM
• Common Device Name: CLINICAL CHEMISTRY
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24586609
• Report Number: 1319681-2026-00015
• Device Sequence Number: 5725097
• Product Code: JJE
• UDI-Device Identifier: 10758750031610
• UDI-Public: (01)10758750031610
• 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
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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 Catalogue Number: 6844461
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2020
• 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