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

Catalog Number 6199949

Device Problem False Negative Result (1225)

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

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant non-reactive vitros sars cov-2 antigen (cv2ag) results were obtained from two different patient samples processed using vitros immunodiagnostic products sars-cov-2 antigen reagent on a vitros xt 7600 integrated system.A definitive cause of the discordant non-reactive vitros cv2ag results was not established.A vitros cv2ag lot 0011 reagent issue is not a likely contributor to the event as quality control results around the time of the event demonstrated acceptable vitros cv2ag lot 0011 reagent performance.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros cv2ag lot 0011.There was no evidence of an instrument malfunction.However, as no precision testing was conducted on the vitros xt 7600 integrated system, an instrument issue cannot be completely ruled out as a contributor to the event.(b)(4).

Event Description

A customer reported discordant non-reactive vitros sars cov-2 antigen (cv2ag) results obtained from two different patient samples processed using vitros immunodiagnostic products sars-cov-2 antigen reagent on a vitros xt 7600 integrated system.Patient 2 vitros cv2ag result of 0.27 s/c (non-reactive) versus the expected result of reactive patient 4 vitros cv2ag result of 0.64 s/c (non-reactive) 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.The vitros cv2ag results were not reported from the laboratory to a physician.Patient management was not influenced based on the vitros results as the vitros cv2ag assay was under validation at the customer site at the time of the event.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11055209
• MDR Text Key: 223850544
• Report Number: 3007111389-2020-00213
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2021
• Device Catalogue Number: 6199949
• Device Lot Number: 0011
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1