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

Catalog Number 09203095190

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys anti-sars-cov-2 results for one patient tested on a cobas 6000 e 601 module serial number (b)(4).At the beginning of (b)(6) 2020, the patient was tested by pcr scratch methodology and had a negative result.The patient did not show any symptoms and was not suspected to be sars-cov-2-infected.The pcr manufacturer and the date of testing were requested but not provided.On (b)(6) 2020, the patient¿s sample was tested with elecsys anti-sars-cov-2 assay, euroimmun sars-cov2-ak elisa igg and iga assay, edi novel coronavirus elisa igm assay, biozol nadal covid-19 igg/igm test, and biopharm wantai total antibody to sars-cov-2 test.The biopharm wantai total antibody to sars-cov-2 test is on the eua list.The euroimmun sars-cov2-ak elisa igg and iga assay, edi novel coronavirus elisa igm assay, and biozol nadal covid-19 igg/igm test are not on the eua list.It was requested but not provided if the elecsys anti-sars-cov-2 result was reported outside the laboratory.The patient¿s euroimmun sars-cov2-ak elisa igg and iga assay result was negative.The patient¿s elecsys anti-sars-cov-2 assay result was repeatedly reactive, 28.25 coi.The patient¿s edi novel coronavirus elisa igm assay result was negative.The patient¿s biozol nadal covid-19 igg/igm test result was negative.The patient¿s biopharm wantai total antibody to sars-cov-2 test result was negative.

Manufacturer Narrative

The patient's sample was provided for investigation.The investigation confirmed the customer's results with the elecsys anti-sars-cov-2 assay.The investigation performed additional measurements by using a rapid assay from creative diagnostics, and an independent in-house roche assay detecting other antibodies against sars-cov-2.The patient's sample produced weak igg reactivity results for the rapid assay, and the patient's sample had a reactive result for the roche assay.The reactive roche assay result provided serological evidence for a past sars-cov-2 infection or at least contact with sufficient amounts of virus or viral fragments to cause an immune reaction.Further clarification of the observed discrepancies is not possible with the currently available methods and state of the art research tools.A general reagent issue could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 10307887
• MDR Text Key: 202777441
• Report Number: 1823260-2020-01766
• 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
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• 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: 495464
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR