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

Catalog Number	6842781
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that discordant non-reactive vitros hiv combo (hivc) results were obtained when an ortho laboratory specialist (ls) was processing vitros hiv p24 antigen control lot 0150 when completing installation of a vitros 3600 integrated system at the customer site.The ortho ls was processing vitros hiv p24 antigen controls when using vitros immunodiagnostics products hivc reagent lot 0970.A definitive assignable cause cannot be determined.A review of the vitros hivc negative, anti-hiv-1 and anti-hiv-2 results prior to the event fell in the appropriate vitros interpretation classification, indicating acceptable accuracy when using measuring hiv antibody using vitros hivc lot 0970.However, this is a hiv combo assay, and the issue is with antigen.An insufficient within run precision test was performed on the vitros 3600 immunodiagnostic system prior to the event, therefore, the marker precision test cannot be used to assess the performance of the vitros 3600 immunodiagnostic system.Additionally, no precision testing was carried out on the day of the event, therefore, an instrument issue cannot be ruled out as a contributor to the event.Sample handling and storage of the hivc p24 antigen control is a possible contributor to the event as it was determined that the controls were not stored correctly at the distributor site and the customer site.Therefore, improper storage is a possible contributor to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant non-reactive vitros hiv combo (hivc) results were obtained when an ortho laboratory specialist (ls) was processing vitros hiv p24 antigen control lot 0150 when completing installation of a vitros 3600 integrated system at the customer site.The ortho ls was processing vitros hiv p24 antigen controls when using vitros immunodiagnostics products hivc reagent lot 0970.Vitros hiv p24 antigen control result of 0.62, 0.62 and 0.67 s/c (negative) vs.The expected result of positive.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The false negative vitros hivc results were obtained when a non-patient fluid was processed when an ortho ls was installing the vitros 3600 immunodiagnostic system at the customer site.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 604580.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO 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: 18480233
• Report Number: 3007111389-2024-00003
• Device Sequence Number: 15147481
• Product Code: MZF
• UDI-Device Identifier: 10758750031580
• UDI-Public: 10758750031580
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• 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): 01/08/2024

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 Expiration Date: 08/03/2024
• Device Catalogue Number: 6842781
• Device Lot Number: 0970
• 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: 12/12/2023
• Initial Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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