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	11/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, false negative hivc results were obtained when multiple samples were tested using vitros hivc lot 0730 and lot 0810 on a vitros xt7600 integrated system.The testing was conducted as part of internal investigational testing at ortho rochester.Sample 1, vitros hivc lot 0730 result of 0.78 s/c (negative) and vitros hivc lot 0810 result of 0.62 s/c (negative) versus the expected result of reactive sample 2, vitros hivc lot 0730 result of 0.30 s/c (negative) and vitros hivc lot 0810 result of 0.12 s/c (negative) versus the expected result of reactive sample 3, vitros hivc lot 0730 result of 0.21 s/c (negative) and vitros hivc lot 0810 result of 0.13 s/c (negative) versus the expected result of reactive sample 4, vitros hivc lot 0730 result of 0.25 s/c (negative) and vitros hivc lot 0810 result of 0.16 s/c (negative) versus the expected result of reactive sample 5, vitros hivc lot 0730 result of 0.23 s/c (negative) and vitros hivc lot 0810 result of 0.15 s/c (negative) versus the expected result of reactive 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 as part of internal investigational testing by ortho.There was no allegation of patient harm as a result of this event.This report is number one 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) nonconformance 0600643 and reportability assessment 600108.
Additional Manufacturer Narrative
The investigation determined that discordant, false negative hivc results were obtained when multiple samples were tested using vitros hivc lot 0730 and lot 0810 on a vitros xt7600 integrated system.The testing was conducted as part of internal investigational testing at ortho rochester.A definitive cause of the discordant, false negative vitros hivc results was not established.Quality control results on the date of the event indicated acceptable vitros hivc lot 0730 and lot 810 performance.Ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros product hivc reagent lot 0730 or lot 0810.However, ortho has initiated an investigation for non-reactive and repeat false reactive patient sample results and vitros hivc lot 0730 is included as a potentially affected lot in this investigation.There was no evidence of an instrument malfunction and qc results were acceptable on the vitros xt7600 integrated system on the date of the event.However, as no diagnostic precision testing was conducted to verify instrument performance, an instrument issue cannot be completely ruled out as a contributor to the event.

• 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: 15887166
• Report Number: 3007111389-2022-00641
• Device Sequence Number: 5113675
• Product Code: MZF
• UDI-Device Identifier: 10758750031580
• UDI-Public: 10758750031580
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/30/2022

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: 02/24/2023
• Device Model Number: 6842781
• Device Catalogue Number: 6842781
• Device Lot Number: 0730
• 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: 11/02/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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