MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT PACK; IN-VITROS 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 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that false negative, non-reactive vitros cv2ag results were obtained from seven different patient samples when tested on a vitros xt7600 integrated system.A definitive assignable cause for the discordant, negative, non-reactive vitros cv2ag results was not established with the information provided.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cv2ag lot 0015 and lot 0021.Based on historical qc results, a vitros cv2ag lot 0015 and lot 0021 reagent performance issue is not a likely contributor to the event as qc fluid results were reported to be within the correct ifu interpretation.There was no indication of an instrument performance issue, however, it cannot be entirely ruled out as a contributing factor as diagnostic precision testing to assess instrument performance was not performed.In addition, pre-analytical sample processing could be ruled out as a contributing factor as it was established that the samples were processed in line with the sample handling guidance in the vitros cv2ag ifu.(b)(4).

Event Description

The investigation has determined that false negative, non-reactive vitros sars-cov-2 antigen (cv2ag) results were obtained from seven different patient samples when tested using two different lots of vitros cv2ag in combination with a vitros xt7600 integrated system.The results were discordant based on positive non-vitros polymerase chain reaction (pcr) results for the same patient samples.Cv2ag lot 0015 results: patient sample 2 result of non-reactive versus the expected result reactive patient sample 5 result of non-reactive versus the expected result reactive cv2ag lot 0021 results: patient sample 1 result of non-reactive versus the expected result reactive patient sample 3 result of non-reactive versus the expected result reactive patient sample 4 result of non-reactive versus the expected result reactive patient sample 6 result of non-reactive versus the expected result reactive patient sample 7 result of non-reactive versus the expected result 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 vitros cv2ag results were reported from the laboratory to a physician.No treatment was altered, initiated or stopped based on the reported results and corrected reports were later issued based on the pcr results.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number three of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.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-VITROS DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 11769175
• MDR Text Key: 280685203
• Report Number: 1319681-2021-00047
• 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: health professional
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• 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: 0021
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1