MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV2 TOTAL REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 6199922

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

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

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant, non-reactive vitros cov2tot results were obtained from samples from two different patients when processed using vitros cov2tot lot 0112 reagent on a vitros 3600 immunodiagnostic system.A definitive assignable cause for the discordant, non-reactive vitros cov2tot results could not be determined.There was no health information provided upon request regarding the current or previous health status for patient 1 or patient 2.The customer only indicated that the cov2tot was a false negative.Based on historical quality control results, a vitros cov2tot lot 0112 reagent performance issue is not a likely contributor to the event as all vitros quality control fluid results prior to the event were within the correct instructions for use (ifu) interpretation region.Additionally, ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros cov2tot lot 0112.There was no indication of an instrument malfunction and unexpected instrument performance was not a likely contributor to the event.It is unknown whether an interferent contributed to the event, as no further testing using a tube to block potential interference in the patient samples was conducted.There was no further sample remaining from patient 1 or patient 2 and a re-draw of the patients was not possible.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions centre (tsc) to report discordant, non-reactive vitros anti- sars-cov-2 total (cov2tot) results obtained from samples from two different patients when tested on a vitros 3600 immunodiagnostic system.The non-reactive vitros cov2tot results were believed to be discordant based on reactive vitros anti- sars-cov-2 igg (cov2igg) results from the patients.Patient 1, vitros cov2tot results of 0.08, 0.09, 0.09 and 0.09 s/c (non-reactive) versus the expected result of reactive.Patient 2, vitros cov2tot results of 0.11 and 0.13 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 on patient samples.It is not known whether the non-reactive vitros cov2tot results for patient 1 or patient 2 were reported from the laboratory.However, ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV2 TOTAL REAGENT PACK
• 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; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10659091
• MDR Text Key: 212056128
• Report Number: 3007111389-2020-00149
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2020
• Device Catalogue Number: 6199922
• Device Lot Number: 0112
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2020
• 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