MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-SARS-COV-2; CORONAVIRUS SEROLOGICAL REAGENT

Catalog Number 09203079190

Device Problem False Positive Result (1227)

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

Event Date 02/10/2022

Event Type  malfunction  

Event Description

The initial reporter received a questionable elecsys anti-sars-cov-2 result for one external quality assessment (eqa) sample compared to other manufacturer assays.The roche analyzer used for testing and the date of the event were requested but not provided.The eqa sample was reportedly provided from a healthy single donor.The eqa sample had a positive result with the elecsys anti-sars-cov-2 assay.The eqa sample had a negative result with the abbott sars-cov-2 igg assay, euroimmun anti-sars-cov-2 ncp elisa igg assay, and shenzen yhlo biotech iflash-sars-cov-2 igg assay.The abbott sars-cov-2 igg assay was tested on both the architect and alinity analyzers.The expected result for the eqa sample was negative.

Manufacturer Narrative

The eqa sample was provided for an investigation.The investigation is ongoing.

Manufacturer Narrative

The investigation reproduced the customer's elecsys anti-sars-cov-2 result.The investigation tested the sample with the elecsys anti-sars-cov-2 s assay, 487 u/ml, and two different rapid tests, both reactive for igg but not igm antibodies.However, the rapid tests do not differentiate between antibodies directed against the nucleocapsid or spike protein.Consistent reactivity of the sample with elecsys anti-sars-cov-2 in all laboratories using this assay indicated a previous unnoticed asymptomatic infection with sars-cov-2.A discrepancy in igg assays may be due to different assay formats used in igg and total antibody assays.Decreasing antibody titers over time have been frequently reported for igg assays, whereas antibody levels remain stable in total antibody assays using the nucleocapsid antigen.Further clarification of the observed discrepancies is not possible with available methods and the current state of the art.

• Brand Name: ELECSYS ANTI-SARS-COV-2
• Type of Device: CORONAVIRUS SEROLOGICAL REAGENT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13711983
• MDR Text Key: 288044250
• Report Number: 1823260-2022-00624
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: EUA200514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09203079190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1