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

Catalog Number 6199949

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant non-reactive vitros sars cov 2 antigen (cv2ag) results were obtained from a patient sample when tested using vitros cv2ag lot 0065 on a vitros xt7600 integrated system.The results were considered discordant when compared to positive pcr results from the same patient.A definitive cause of the event was not determined.Based on qc results obtained around the time of the event, a vitros cv2ag lot 0065 reagent performance issue is not a likely contributor to the event.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cv2ag lot 0065.There was no evidence of an instrument malfunction.However, diagnostic precision testing was not conducted on the instrument around the time of the event.Therefore, an instrument issue cannot be ruled out as a contributor to the event.The viral transport media (vtm) being used was a thermo vtm.An ortho laboratory specialist reported that thermo vtm recently had a product notification released and the customer is now looking for an alternative vtm.Therefore, an issue with the vtm used by the customer cannot be ruled out as a potential contributor to the event.The tsc reviewed the extraction process and the customer indicated that they have observed some mucous in the sample that does not completely break down when vortexing and can cause metering issues on occasion.Therefore, an issue with pre-analytical sample handling that could cause poor sample quality is a potential contributor to the event.(b)(4).

Event Description

The investigation determined that discordant non-reactive vitros sars-cov-2 antigen (cv2ag) results were obtained from a patient sample when tested using vitros cv2ag lot 0065 on a vitros xt7600 integrated system.The results were considered discordant when compared to a positive pcr results from the same patient.Vitros cv2ag = non-reactive (0.99, 0.74 s/c) versus expected positive biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.A discordant non-reactive vitros cv2ag result was reported from the laboratory.However, the result was questioned by the laboratory and the sample was sent for confirmation pcr testing.There was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 11768195
• MDR Text Key: 280685112
• Report Number: 1319681-2021-00044
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial
• Report Date: 05/04/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 6199949
• Device Lot Number: 0065
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1