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

Catalog Number 09203079190

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

The qc results did not indicate a reagent issue.The sensitivity of the elecsys anti-sars-cov-2 assay early after infection is unknown.Negative results do not preclude acute sars-cov-2 infection.If acute infection is suspected, direct testing for sars-cov-2 is necessary.As the sample was not available, the investigation did not identify a product problem.The cause of the event could not be determined.The maglumi cmia assay does not appear to have eua (emergency use authorization) approval.(b)(6).

Event Description

The initial reporter received a questionable anti-sars-cov-2 elecsys result for one patient from cobas e 801 module serial number (b)(4).On (b)(6) 2020, the rt-pcr result was 27.68.On (b)(6) 2020, the covidg result was 0.02 (non-reactive) and the covidm (reactive) result was 6.22 by maglumi - cmia.The anti-sars-cov-2 elecsys result was 0.0822 (non-reactive).It is unknown which result was correct.The questionable result was not reported outside of the laboratory.

• 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: 10252745
• MDR Text Key: 199071242
• Report Number: 1823260-2020-01650
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• 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: 495040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR