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

Model Number	6801812
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, reactive anti-hav igm (ahavm) results were obtained from two samples from the same patient when tested using vitros ahavm lot 5750 on a vitros 3600 immunodiagnostic system.The vitros ahavm results were discordant when compared to vitros ahavt results from the same patient samples and a hepatitis a rna result for the patient which did not suggest acute hepatitis a infection.Patient 1, sample 1, vitros ahavm results of 7.93, 7.87 and 7.77 s/c (reactive) versus the expected result of non-reactive patient 1, sample 2, vitros ahavm results of 4.23 and 4.53 s/c (reactive) versus the expected result of non-reactive biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, reactive vitros ahavm results were not reported from the laboratory.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 602214.
Additional Manufacturer Narrative
The investigation determined that discordant, reactive anti-hav igm (ahavm) results were obtained from two samples from the same patient when tested using vitros ahavm lot 5750 on a vitros 3600 immunodiagnostic system.The vitros ahavm results were discordant when compared to vitros ahavt results from the same patient samples and a hepatitis a rna result for the patient which did not suggest acute hepatitis a infection.A definitive cause of the discordant, reactive vitros ahavm results was not established with the limited information provided.The event was isolated to samples from a single patient.Interference in the samples for the patient cannot be ruled out as a contributor to the event.It is possible that an interferent that affects the vitros ahavm reagent assay contributed to the event, however, this could not be confirmed as no testing to rule out an interferent was conducted at the time of writing this report.A vitros ahavm lot 5750 reagent issue cannot be ruled out as a contributor to the event, as no historical qc results were provided when requested to verify the performance of the vitros ahavm lot 5750 reagent assay.However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ahavm lot 5750.There was no indication of a vitros instrument malfunction and vitros ahavt results for the patient sample were as expected.However, no diagnostic within run precision testing was conducted around the time of the event to verify instrument performance.Therefore, issues with the vitros 3600 immunodiagnostic systems cannot be entirely ruled out as a contributor to the event.Pre-analytical sample processing could not be ruled out as a contributing factor as it was not possible to determine whether the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM 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: 17115536
• Report Number: 3007111389-2023-00087
• Device Sequence Number: 15115926
• Product Code: LOL
• UDI-Device Identifier: 10758750001415
• UDI-Public: 10758750001415
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/12/2023

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: 08/07/2023
• Device Model Number: 6801812
• Device Catalogue Number: 6801812
• Device Lot Number: 5750
• 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: 05/18/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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