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

Model Number	6842781
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, negative vitros hiv combo (hivc) lot 0460 results were obtained from patient specimens when tested on two vitros 5600 integrated systems.The vitros hivc results were discordant compared to non-vitros (lateral flow) method results and vitros hivc repeat results for the samples.Specimen 4, vitros hivc initial results of 0.09 and 0.15 s/c (negative), vitros hivc repeat results of 0.35 and 0.17 s/c (negative) versus a positive lateral flow result specimen 10, vitros hivc initial results of 0.12 and 0.11 s/c (negative) versus a positive lateral flow result and repeat vitros hivc results of 1.86 and 1.64 (reactive) specimen 17, vitros hivc initial results of 0.07 and 0.13 s/c (negative) versus a positive lateral flow result and repeat vitros hivc results of 6.79 and 6.36 s/c (reactive) specimen 18, vitros hivc initial results of 0.14 and 0.20 s/c (negative) versus a positive lateral flow result and repeat vitros hivc results of 56.57 and 47.26 s/c (reactive) the discordant, negative vitros hivc results were not reported from the laboratory as the vitros hivc reagent method was under validation at the customer site when the discordant results were obtained.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that discordant, negative vitros hiv combo (hivc) lot 0460 results were obtained from patient specimens when tested on two vitros 5600 integrated systems.The vitros hivc results were discordant compared to non-vitros (lateral flow) method results and vitros hivc repeat results for the samples.A definitive cause of the event was not established.Improper handling of the specimens is a possible contributor to the event, as the customer was unsure how long to allow specimens to thaw and that the specimens were not re-spun prior to processing on the instrument.The vitros hivc instructions for use (ifu) states to allow specimens to come to 15-30 °c before use and thoroughly mix the sample prior to processing.Vitros hivc lot 0460 quality control (qc) fluid results were acceptable on the dates of specimen testing, however, the customer did not process sufficient hivc qcs to assess the performance of vitros hivc reagent lot 0460.There was no evidence of instrument issues, however, as diagnostic precision testing was not conducted throughout the time the discordant, negative vitros hivc results were obtained, instrument issues cannot be completely ruled out as contributors to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros hivc lot 0460.

• 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: 16015048
• Report Number: 3007111389-2022-00672
• Device Sequence Number: 7426436
• Product Code: MZF
• UDI-Device Identifier: 10758750031580
• UDI-Public: 10758750031580
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2022

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: 07/31/2023
• Device Model Number: 6842781
• Device Catalogue Number: 6842781
• Device Lot Number: 0460
• 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: 11/22/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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