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

Catalog Number 6199919

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that reproducible and discordant vitros cov2igg results were obtained from a single patient sample when tested using vitros cov2igg lot 0160 on a vitros eciq immunodiagnostic system.The results were discordant when compared to non-reactive vitros cov2tot results from the same patient sample.A definitive cause of the discordant reactive vitros cov2igg results was not determined.The patient that produced the discordant vitros results was drawn from the physician who was performing a study on healthy blood donors using the vitros covid assays.The physician was healthy and had no history of symptoms associated with a covid-19 infection.There were no options for pcr testing or alternate antibody testing to assist with investigation.Based on the patient history it was concluded that the cov2igg was a false reactive result.A vitros cov2igg lot 0160 reagent issue is an unlikely contributor to the event, as acceptable results were obtained on the day of initial testing and subsequent patient results were similar to the initial results.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros cov2igg reagent lot 0160.Unexpected instrument performance is not a likely contributor to the events.However, it cannot be entirely ruled out as a contributing factor as precision testing to assess instrument performance was not performed by the customer when requested.Improper pre-analytical sample handling was a potential contributor to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.A heterophilic or non-specific antibody interferent was ruled out as the cause of the discordance between vitros cov2tot and vitros cov2igg results, as the results obtained using the sample treated with a nabt and hbt were concordant (cov2igg reactive) with results from untreated samples.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions centre (tsc) to report discordant reactive vitros anti- sars-cov-2 igg (cov2igg) results obtained from a single patient sample when tested on a vitros eciq immunodiagnostic system.The vitros cov2igg results were believed to be discordant based on non-reactive vitros anti- sars-cov-2 total (cov2tot) results from the same patient sample.Vitros cov2igg result of 2.65, 2.74, and 2.45 s/c (reactive) versus the expected result of non-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 cov2igg results were not reported from the laboratory.There was no 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 IGG 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; 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: 10302102
• MDR Text Key: 200963029
• Report Number: 3007111389-2020-00074
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2020
• Device Catalogue Number: 6199919
• Device Lot Number: 0160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2020
• 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