MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT PACK; IN-VITRO DIAGNOSTICS

Model Number	6199949
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that discordant reactive vitros sars-cov-2 antigen (cv2ag) results were obtained from a single patient sample when tested using vitros cv2ag lot 2040 on a vitros xt 7600 integrated system.The results were considered discordant as a negative pcr result was obtained for the patient.Additionally, a non-reactive vitros cv2ag result was obtained when the sample from the patient was retested.A definitive cause of the discordant false reactive vitros cv2ag results was not determined.A vitros cv2ag lot 2040 reagent issue is not a likely contributor to the event as historical qc results as well as results on the date of the event were within acceptable guidelines.In addition, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros cv2ag lot 2040.An instrument issue cannot be completely ruled out as a contributor to the event as diagnostic precision testing to verify instrument performance was not completed.However, there was no indication of an instrument related issue as an expected vitros cv2ag result was obtained for the patient through repeat testing without any known actions being performed on the vitros xt 7600 system.The initial nasopharyngeal swab sample obtained from the patient was described as cloudy and viscous by the customer.Therefore, a sample related issue cannot be completely ruled out as a contributor to the event.Additionally, the initial vitros reactive result was reproducible as repeat testing of the initial extract was also reactive.However, after centrifugation of the initial sample, a non-reactive result was obtained.Therefore, pre-analytical sample processing cannot be ruled out as a contributing factor of the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant reactive vitros sars-cov-2 antigen (cv2ag) results were obtained from a single patient sample when tested using vitros cv2ag lot 2040 on a vitros xt 7600 integrated system.The results were considered discordant as a negative pcr result was obtained for the patient.Additionally, a non-reactive vitros cv2ag result was obtained when the sample from the patient was retested.Vitros cv2ag results of reactive (1.31 and 1.07 s/c) versus 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 false reactive vitros cv2ag results were reported from the laboratory to a physician.However, no treatment was initiated, altered or stopped based on the reported results.There was no 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).
Additional Manufacturer Narrative
Ortho received an email from fda on 25 jan 2023.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant reactive vitros sars-cov-2 antigen (cv2ag) results were obtained from a single patient sample when tested using vitros cv2ag lot 2040 on a vitros xt 7600 integrated system.The results were considered discordant as a negative pcr result was obtained for the patient.Additionally, a non-reactive vitros cv2ag result was obtained when the sample from the patient was retested.Vitros cv2ag results of reactive (1.31 and 1.07 s/c) versus 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 false reactive vitros cv2ag results were reported from the laboratory to a physician.However, no treatment was initiated, altered or stopped based on the reported results.There was no 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 600315.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN 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: 15992194
• Report Number: 3007111389-2022-00669
• Device Sequence Number: 14825321
• Product Code: QKP
• UDI-Device Identifier: 10758750033584
• UDI-Public: 10758750033584
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 01/27/2023
• 2 Devices were Involved in the Event: 1 2

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: 11/21/2022
• Device Model Number: 6199949
• Device Catalogue Number: 6199949
• Device Lot Number: 2040
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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