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

Catalog Number	6197735
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros b¿r¿a¿h¿m¿s procalcitonin (pct) qc fluid results were obtained from vitros b¿r¿a¿h¿m¿s pct lot 0360 level 2 quality control (qc) fluid, using vitros immunodiagnostic products b¿r¿a¿h¿m¿s pct reagent on a vitros 5600 integrated system vitros b¿r¿a¿h¿m¿s pct level 2 results of 0.03 and 0.03 ng/ml versus the expected result of 1.91 ng/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 b¿r¿a¿h¿m¿s pct results were from non-patient fluid.The customer did not give any indication that patient results had been affected and there is 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).
Additional Manufacturer Narrative
The investigation has determined that lower than expected vitros b¿r¿a¿h¿m¿s procalcitonin (pct) qc fluid results were obtained from vitros b¿r¿a¿h¿m¿s pct lot 0360 level 2 quality control (qc) fluid, using vitros immunodiagnostic products b¿r¿a¿h¿m¿s pct reagent on a vitros 5600 integrated system a definitive assignable cause for the lower than expected vitros b¿r¿a¿h¿m¿s pct results could not be determined.Based on historical quality control results, a vitros b¿r¿a¿h¿m¿s pct reagent lot 0370 performance issue is not a likely contributor to the event.Additionally, the customer indicated that the vitros 5600 integrated system was having some issues at the time of the event with well wash temperature and the compressor.However, the customer did not perform an appropriate within run precision test at the time of the event to definitively rule out an instrument issue and therefore, unexpected instrument performance cannot be ruled out as contributing to the event.Handling and processing of the vitros qc samples could be ruled out as a contributing factor as it was established the customer was following the control storage, preparation and handling requirements as detailed in the vitros b¿r¿a¿h¿m¿s pct controls instructions for use.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros b¿r¿a¿h¿m¿s pct reagent lot 0370.

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18382573
• Report Number: 3007111389-2023-00214
• Device Sequence Number: 20785103
• Product Code: PMT
• UDI-Device Identifier: 10758750033287
• UDI-Public: 10758750033287
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (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): 12/21/2023

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: 05/16/2024
• Device Catalogue Number: 6197735
• Device Lot Number: 0370
• 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: 12/05/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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