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 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).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.The patient sample 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 e801 module.On 19-may-2020 the patient had a positive pcr result.On 23-jun-2020 the patient sample was tested multiple times on the e801 module with negative results (0.198 coi).On 24-jun-2020 the patient sample was tested multiple times by the diasorin method with positive results (24.2 au/ml) it is not known if any questionable results were reported outside of the laboratory.The e801 module serial number was (b)(4).

Manufacturer Narrative

Section d4, lot number and expiration date were updated.Calibration and qc at the customer site was acceptable.The patient sample was submitted for investigation.The customer's result was reproduced with the elecsys anti-sars-cov-2 assay.Additional measurements determined this sample as positive with a rapid assay (weak igg) from creative diagnostics as well as an independent in-house roche assay detecting other antibodies against sars-cov-2.Given that the patient is regularly exposed to the common cold corona viruses (hku1, 229e, oc43 and nl63), an effective anti-corona-virus immune response might be in place, therefore differing from immune responses of naïve patients.As the determined coi-value for the investigated sample was slightly elevated after 30 days post positive pcr, a follow-up sample would be expected to result as positive.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: 10310564
• MDR Text Key: 200839145
• Report Number: 1823260-2020-01768
• 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: 09203079190
• Device Lot Number: 496292
• 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
• Patient Age: 52 YR