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

Catalog Number 6199949

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Date 12/13/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant non-reactive and discordant reactive vitros sars cov 2 antigen (cv2ag) results were obtained from samples from multiple different patients when tested using vitros cv2ag lot 0014 on two different vitros 5600 integrated systems a definitive cause of the discordant false non-reactive and the discordant false reactive vitros cv2ag results was not determined.Discordant vitros cv2ag results were obtained on (b)(6) 2020 and (b)(6) 2021, therefore it is possible that potential causes of the events varied between each date.An issue with the customer¿s vitros 5600 integrated systems cannot be ruled out as a contributor to the event, as the results for patients 2, 3, 5 and 11 were discordant when compared to vitros cv2ag from the customer¿s other vitros 5600 integrated system.An ortho fe was due to visit the customer site to verify the performance of the instruments on (b)(6) 2021.No information was provided regarding the handling of the nasopharyngeal patient samples, therefore a patient sample handling issue cannot be ruled out as a contributor to the event.A vitros cv2ag lot 0014 reagent issue is an unlikely contributor to the event, as qc results around the time of the discordant vitros cv2ag results were acceptable.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 0014.A definitive assignable cause for the event could not be determined.(b)(4).

Event Description

A customer reported both discordant non-reactive and reactive vitros sars cov 2 antigen (cv2ag) results obtained from samples from multiple different patients when tested using vitros cv2ag lot 0014 on two different vitros 5600 integrated systems.The results were discordant compared to pcr results from the same patient samples.Additionally, vitros cv2ag results were also discordant against alternative vitros cv2ag results for the same patients in some cases.False non-reactive vitros cv2ag results: patient 3, vitros cv2ag result of 0.97 s/c (non-reactive) versus a vitros cv2ag result of 1.01 s/c (reactive) and a positive pcr result.Patient 6, vitros cv2ag results of 0.90, 0.34 s/c (non-reactive) versus a positive pcr result.Patient 7, vitros cv2ag results of 0.87, 0.41 s/c (non-reactive) versus a positive pcr result.Patient 8, vitros cv2ag results of 0.69, 0.61 s/c (non-reactive) versus a positive pcr result.Patient 9, vitros cv2ag results of 0.59, 0.40 s/c (non-reactive) versus a positive pcr result.Patient 11, vitros cv2ag result of 0.73 s/c (non-reactive) versus a vitros cv2ag result of 1.23 s/c (reactive) and a positive pcr result.False reactive vitros cv2ag results: patient 2, vitros cv2ag result of 1.08 s/c (reactive) versus a negative pcr result.Patient 5, vitros cv2ag result of 1.42 s/c (reactive) versus a negative pcr result.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 and patient management was not influenced based on the vitros results as the vitros cv2ag reagent assay was under validation at the customer site.There was no allegation of actual 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).

Manufacturer Narrative

This supplemental mdr was created to update the likely assignable cause for the false reactive vitros sars cov-2 antigen results to be due to an issue with the performance of the remel m4rt.A follow up with the customer after the initial mdr was sent identified the customer was using remel m4rt vtm.Ortho has determined it is possible for the remel m4rt vtm to generate higher than expected signal/cutoff (s/c), which may result in a falsely reactive result, even in the absence of a specimen swab.A communication (b)(6) was sent to all consignees on (b)(6) 2021 and informed customers to discontinue use of remel m4rt vtm and transition to an alternate media.The vitros sars-cov-2 antigen instructions for use has been updated to remove remel m4rt vtm from the intended use and the specimens recommended sections.The fda was notified of this issue on 11 february 2021.Please refer to report #1319681-02/18/2021-001-c (res87356).

Event Description

This supplemental mdr was created to update assignable cause to include an issue with the performance of the remel m4rt as a likely cause of the false reactive results.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4) and (b)(4).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.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 11169267
• MDR Text Key: 228020795
• Report Number: 1319681-2021-00003
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2021
• Device Catalogue Number: 6199949
• Device Lot Number: 0014
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1