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

Catalog Number 09203095190

Device Problems False Positive Result (1227); Insufficient Information (3190)

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

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

This information was reported in the laboratory medicine article, a persistent positive antibody test in a patient with no history of covid-19 infection.

Event Description

There was an allegation that one patient received repeatable false positive results from the elecsys anti-sars-cov-2 assay on unknown roche analyzers.The results did not agree with the clinical picture of the patient.Approximately 10 days prior to (b)(6) 2020, the patient reported a potential exposure to covid-19 through close interaction with a family member who had direct exposure to someone diagnosed with covid-19.The patient received a sars-cov-2 reverse transcription-polymerase chain reaction (rt-pcr) test using a self-administered throat swab that returned negative.On (b)(6) 2020, a sample from the patient was also evaluated using the elecsys anti-sars-cov-2 assay, resulting in a value of 3.51 coi (positive).Because the patient and her family received negative sars-cov-2 rna and antibody tests and showed no evidence of sars-cov-2 infection, the patient¿s immune response was re-evaluated on (b)(6) 2021 with a second serum specimen using the abbott architect i2000sr platform to test for plasma igg antibodies.This test returned a negative result.The first sample from (b)(6) 2020 was repeated with the elecsys anti-sars-cov-2 assay on (b)(6) 202, resulting in a value of 3.54 coi (positive).A third sample was collected from the patient on (b)(6) 2020 and portions of this sample were sent to two laboratories.Both laboratories tested the sample using the elecsys anti-sars-cov-2 assay, resulting in values of 3.36 coi (positive) and 3.6 coi (positive).One of the two laboratories also tested this sample using the abbott igg test, resulting in a value of 0.1 coi (negative).

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.A patient was tested because of a close contact with somebody who had contact with a person infected with covid-19.Samples were taken 10 and 17 days after this contact.This time is relatively short if the development of an infection is to be considered.Testing of the 2 anti-sars-cov-2 antibody assays were measured which gave discrepant results (abbott anti-sars-cov-2 igg negative and elecsys anti-sars-cov-2 positive).The positive results were confirmed in a consecutive draw.Coi-values were similar between the draws.This does not support an early infection phase.The fact that the family members did not show positive antibody results cannot be taken as a proof that the elecsys result must be false-positive.

• 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: 12241591
• MDR Text Key: 272658208
• Report Number: 1823260-2021-02203
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09203095190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2021
• 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
• Patient Age: 45 YR