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

Catalog Number	6197735
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a non-reproducible, higher than expected vitros procalcitonin (pct) result was obtained from a sample from a single patient when tested on a vitros xt 7600 integrated system using reagent lot 0440 when compared to a repeat pct test result obtained from a repeat test of the same sample on the same vitros xt 7600 integrated system.A definitive assignable cause for the non-reproducible, higher than expected vitros pct result could not be determined with the information provided.Based on historical quality control results, a vitros pct performance issue is not a likely contributor to the event.In addition, the repeat test result of 0.059 ng/ml was processed using the same vitros pct reagent pack, further supporting that the vitros pct reagent lot 0440 is not a contributor to the event.There is also no indication of an instrument, however, an instrument issue cannot be entirely ruled out as a contributing factor as precision testing to assess instrument performance was not performed by the customer at the time of writing this report.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was unknown if the customer was following the sample collection device manufacture's recommendation for sample centrifugation.Given that multiple analyte results from the initial test event were discordant when compared to any of the five repeat test events of the same patient sample, the ortho technical solutions center (tsc) investigated whether or not a pre-analytical patient sample mix up contributed to this event.However, findings from this investigation using econnectivity were inconclusive.Therefore, it is possible that a pre-analytical patient sample mix up had contributed to this event, but this could not be confirmed.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros pct reagent lot 0440.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected vitros procalcitonin (pct) result was obtained from a sample from a single patient when tested on a vitros xt 7600 integrated system using reagent lot 0440 when compared to a repeat pct test result obtained from a repeat test of the same sample on the same vitros xt 7600 integrated system.Patient sample result of 1.916 ng/ml versus the expected (reported) repeat result of 0.059 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected, the non-reproducible, higher than expected vitros pct result of 1.916 ng/ml was questioned by the laboratory staff and repeat test events were subsequently processed.The questioned result was not reported from the laboratory and there has been 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 (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS BRAHMS PCT 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21559949
• Report Number: 3007111389-2025-00020
• Device Sequence Number: 4430418
• Product Code: PMT
• UDI-Device Identifier: 10758750033287
• UDI-Public: (01)10758750033287(17)250806(11)240924(10)0440
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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: 08/06/2025
• Device Catalogue Number: 6197735
• Device Lot Number: 0440
• 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: 02/12/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• 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