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

Catalog Number 09203095190

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for two samples from the same patient tested with the elecsys anti-sars-cov-2 assay on a cobas 6000 e 601 module.The patient was tested with an unknown molecular diagnostics test on (b)(6) 2020 and tested positive for covid-19.On (b)(6) 2020, the first sample from the patient was tested with the elecsys anti-sars-cov-2 assay, resulting with a value of 0.167 coi (non-reactive).On (b)(6) 2020, the second sample from the patient was tested with the elecsys anti-sars-cov-2 assay, resulting with a value of 0.171 coi (non-reactive).This sample was also repeated using the lyher novelcoronavirus (2019-ncov) rapid igm/igg antibody test and both igg and igm were positive.It is unknown which result was considered to be correct.It was stated that the patient is still positive with an unknown pcr test.The serial number of the e 601 analyzer is (b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation and the results obtained by the customer could not be reproduced.Investigations found the sample to be clearly reactive with the elecsys anti-sars-cov-2 assay.A competitor rapid test also showed igg reactivity.The last calibration performed on 02-nov-2020 showed signals within the expected range.Quality controls were within range on 19-nov-2020 and 20-nov-2020.A general reagent issue can be excluded.A general product problem was not found.

Manufacturer Narrative

A second sample from the same patient was tested with a second lot number (lot 527896) of the elecsys anti-sars-cov-2 assay on the same e 601 analyzer on (b)(6) 2021.The elecsys anti-sars-cov-2 value from the e 601 analyzer was 0.113 coi (non-reactive).This sample was also tested with the elecsys anti-sars-cov-2 s assay on a cobas e 411 immunoassay analyzer (serial number (b)(4)) on (b)(6) 2021, resulting with a value of 19.86 u/ml (reactive).

Manufacturer Narrative

The second patient sample was provided for investigation.The results obtained by the customer could be duplicated.The sample was measured using the elecsys anti-sars-cov-2 s assay and two different rapid tests.Based on the acquired results, it seems that only antibodies against the sars-cov-2 spike protein were present in this sample.

• 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
• MDR Report Key: 11023470
• MDR Text Key: 244561787
• Report Number: 1823260-2020-03259
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 512339
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1