MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM; CHEMISTRY ANALYZER

Model Number	1922814
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower than expected vitros b-hcg ii result was obtained when vitros reproductive endocrine quality control fluids were tested using vitros b-hcg ii lot 3790 on a vitros eci immunodiagnostic system.The most likely assignable cause of the event is microwell incubator contamination.The customer stated that their analyzer was located near the bathrooms in their facility, and that they clean using chlorine bleach.Per the vitros eci instructions for use: soapy water is used for general cleaning; however, a 2% solution of fl-70 in water may be used in place of soapy water.Do not use sodium hypochlorite, bleach, ammonia, or any ammonia-containing compound, or any other oxidizing agents to clean any system components.Such use may result in erroneous results and may also corrode metal parts.Although the customer was not cleaning the analyzer directly with bleach, it is possible for the fumes to lead to erroneous results on the system.The customer relocated the analyzer away from the bathroom and performed the microwell incubator decontamination procedure, after which the vitros b-hcg results returned to expectation.Historical vitros b-hcg ii lot 3790 results from biorad qcs indicated acceptable reagent performance, therefore ruling out an issue with the reagent lot.Additionally, continual tracking and trending does not indicate a systemic issue with vitros b-hcg reagent lot 3790.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected vitros b-hcg ii result was obtained when vitros reproductive endocrine quality control fluids were tested using vitros b-hcg ii lot 3790 on a vitros eci immunodiagnostic system.Vitros re level 1 control lot 0870 b-hcg lot 3790 result of 4.68 versus the expected result of 10.39 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-hcg ii result was obtained when the customer was processing a non-patient fluid.Ortho has not been made aware of any 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 ECIQ IMMUNODIAGNOSTIC SYSTEM
• Common Device Name: CHEMISTRY ANALYZER
• 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18711919
• Report Number: 1319681-2024-00009
• Device Sequence Number: 12810058
• Product Code: KHO
• UDI-Device Identifier: 10758750000272
• UDI-Public: 10758750000272
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2024

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 Model Number: 1922814
• Device Catalogue Number: 1922814
• 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: 01/19/2024
• Initial Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2003
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown