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 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The initial reporter received negative elecsys anti-sars-cov-2 results for one patient tested on a cobas 8000 e 602 module serial number (b)(4).The patient was previously tested with an unknown pcr methodology.The first positive pcr result was performed on (b)(6) 2020.All of the patient samples were tested with menarini covid-19 igg/igm rapid test cassette.Some samples were tested with antibody assays biozek medical covid-19 igg/igm rapid test, innovita 2019-ncov ab test, wondfo sars-cov-2 antibody test, and abbott sars-cov-2 igg assay.The menarini, biozek, innovita, and wondfo antibody assays are not eua approved.

Manufacturer Narrative

The customer's calibration and qc data provided were ok.The customer provided the patient's sample for investigation.The investigation confirmed the customer's elecsys anti-sars-cov-2 result, 0.550 non-reactive.The patient's result of 0.550 coi showed a very weak reaction, but it is distinguishable from negative samples ((b)(4) measurements show a coi of 0.2 or less).Tested with creative diagnostics covid19 test igg/igm rapid test, the patient had a reactive igg and igm result.Tested with an independent roche internal research in-house sars-cov2 antibody assay, the patient had a reactive result.Per product labeling, "a negative test result does not rule out the possibility of an infection with sars-cov-2.Serum or plasma samples from the early (pre-seroconversion) phase of illness can yield negative findings.Therefore, this test cannot be used to diagnose an acute infection.Also, over time, titers may decline and eventually become negative." further clarification of the observed discrepancies is not possible with available methods and the current state of the art based on the available data, a general product problem is 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: 10186182
• MDR Text Key: 203508292
• Report Number: 1823260-2020-01521
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• 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: 496298
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR