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 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined discordant reactive vitros anti- sars-cov-2 total (cov2tot) results were obtained from multiple patient samples processed using vitros cov2tot reagent lot 0021 on a vitros eci immunodiagnostic system.It was concluded that the vitros cov2tot results were false positives.The pcr results for all patients were negative.With a negative pcr result, it is possible that the individual is recovering from an infection if the cov2tot and cov2igg results are both positive.It is also possible that there was no infection if both cov2tot and cov2igg were negative.As the patients were asymptomatic and there was no known exposure to a covid-19 infected person, and they were pcr negative it was expected that the vitros cov2tot and cov2igg would be negative.A false positive anti-sars-cov-2 total antibody test result may indicate a recovery from past infection and immunity.This could potentially put the person into a higher risk category for future infections due to a false assurance of immunity.Therefore, this is a reportable event.Quality control results provided for the date of sampling were as expected, therefore vitros cov2tot lot 21 was performing as expected on the days of the events.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with the vitros cov2tot lot 21.A heterophilic or non-specific antibody interferent cannot be ruled out as the samples were not treated with a heterophile blocking tube (hbt) or a non-specific antibody blocking tube (nabt).The customer experienced unknown mechanical codes that occurred during the timeframe that the samples were run, and an ortho field engineer went to the customer site to resolve the codes.Due to the unknown mechanical issues that were occurring during this timeframe, an instrument issue cannot be entirely ruled out as a cause of the events.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report discordant reactive vitros anti- sars-cov-2 total (cov2tot) results obtained from multiple patient samples processed using a vitros eci immunodiagnostic system.Patient 1 vitros cov2tot = 1.17 s/c (reactive) versus expected non-reactive/negative.Patient 2 vitros cov2tot = 2.13 s/c (reactive) versus expected non-reactive/negative.Patient 3 vitros cov2tot = 3.39, and 3.57 s/c (reactive) versus expected non-reactive/negative.Patient 4 vitros cov2tot = reactive result versus expected non-reactive/negative.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 cov2tot results were reported from the laboratory, however there is no indication that any treatment was altered based on the results.There was no allegation of patient harm as a result of this event.This report is number 4 of 4 mdr¿s for this event.Four (4) 3500a forms are being submitted for this event as 4 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (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; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10638524
• MDR Text Key: 211533660
• Report Number: 1319681-2020-00091
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• 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: 6199922
• Device Lot Number: 0021
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2020
• 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