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 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer did not use the required rack adapters for 13 mm sample tubes for the result on (b)(6) 2020.The customer used rack adapters for the result on (b)(6) 2020.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.Sample material was requested for investigation.

Event Description

The initial reporter complained of discrepant negative results for 1 patient tested for elecsys anti-sars-cov-2 (anti-sars-cov-2) on a cobas 6000 e 601 module.The patient had a positive roche pcr test on (b)(6) 2020.On (b)(6) 2020 the patient had an anti-sars-cov-2 result from the e602 module of 0.333 coi (negative).A new sample from the patient was obtained on (b)(6) 2020 and the result from the e602 module was 0.563 coi (negative).No questionable results were reported outside of the laboratory.The e601 module serial number was (b)(4).

Manufacturer Narrative

Calibration and qc at the customer site was acceptable.A "sample short" alarm was observed on the alarm trace data suggesting a general pre-analytical handling issue at the customer site.The customer did not use the required rack adapters for 13 mm sample tubes for the result on (b)(6) 2020.Product labeling states rack adapters are to be used with 13 mm sample tubes.The sample from (b)(6) 2020 was submitted for investigation.The customer's result was reproduced with the elecsys anti-sars-cov-2 assay.Additionally, the sample was processed in a rapid assay as well as in a roche in-house, independent assay, which also detects antibodies against sars-cov-2.The sample showed an elevated coi in the acov2 assay and a positive result in the roche in-house assay.The sample was found positive in the rapid assay.Given the special working environment, and the serological result, the assumption is that the patient had been exposed to a low amount of sars-cov-2 virus which led to a fairly productive infection with a weak immune response caused by low amounts of virus/ viral fragments presented to the immune system.A general reagent issue can be excluded.The investigation did not identify a product problem.

• 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: 10310668
• MDR Text Key: 202778044
• Report Number: 1823260-2020-01767
• 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: 08/12/2020

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 Expiration Date: 06/30/2020
• Device Catalogue Number: 09203095190
• Device Lot Number: 49629800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1