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

Catalog Number 6199922

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

Patient Problem Insufficient Information (4580)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant negative vitros anti- sars-cov-2 total results were obtained from four different patient samples processed using vitros cov2tot reagent lot 0285 on a vitros 3600 immunodiagnostic system.A definitive assignable cause for the discordant, non-reactive vitros cov2tot results could not be determined.Patient 2 had tested pcr positive 1 day prior to vitros testing and patient 4 had tested pcr positive approximately 3 weeks prior to vitros testing.In addition, the vitros cov2igg result was reactive.The vitros anti-sars cov-2 total assay detects the presence of igm, iga, and/or igg antibodies.Igm antibodies to sars-cov-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized.Igg antibodies to sars-cov-2 become detectable later following infection, although detection of igg antibodies does not exclude recently infected individuals who are still contagious.It was expected that the vitros cov2tot would be concordant with the reactive vitros cov2igg results and the reactive covid-19 pcr result.For patients 1 and 3, the vitros cov2tot results were discordant against vitros cov2igg results obtained from the same patient samples.There were no pcr results provided and no clinical information provided about these patients to aid in the determination of truth.However, the customer indicated the cov2igg reactive results were the expected results and it was expected that the vitros cov2tot would be concordant with the vitros cov2igg results as the cov2tot measures igg along with igm and iga.Based on historical quality control results, a vitros cov2tot lot 0285 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 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 0285.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.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.The customer provided no information concerning the sample collection device used to collect the affected samples or sample processing of the affected samples.Therefore, pre-analytical sample handling cannot be ruled out as a potential contributor to this event.A definitive assignable cause of the event was not determined.(b)(4).

Event Description

A customer obtained discordant negative vitros anti- sars-cov-2 total results from four different patient samples processed using vitros cov2tot reagent lot 0285 on a vitros 3600 immunodiagnostic system.Patient 1 vitros cov2tot = non-reactive (0.89 s/c) versus expected reactive.Patient 2 vitros cov2tot = non-reactive (0.52 s/c) versus expected reactive.Patient 3 vitros cov2tot = non-reactive (0.89 s/c) versus expected reactive.Patient 4 vitros cov2tot = non-reactive (0.35 s/c) versus expected reactive.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.It is unknown of the vitros cov2tot results were reported from the laboratory.However, ortho has not been made aware of any allegations of actual patient harm as a result of this event.This report is number two of four mdr¿s for this event.Four 3500a forms are being submitted for this event as four devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-SARS-COV-2 TOTAL REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: laurie o'riordan ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11300363
• MDR Text Key: 232381010
• Report Number: 3007111389-2021-00020
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: RO
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2021
• Device Catalogue Number: 6199922
• Device Lot Number: 0285
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1