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

Catalog Number 09203095190

Device Problems False Positive Result (1227); High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation determined the customer was not using the required rack adapters while using 13mm tubes and the customer did not perform level 2 qc.Product labeling states: "not using a roche rack cup adapter with 13 mm tubes or incorrect use of a roche rack cup adapter may cause incorrect results or errors.Always use roche rack cup adapters with 13mm tubes.".

Event Description

The initial reporter received questionable elecsys anti-sars-cov-2 results for 1 patient sample on a cobas e 411 immunoassay analyzer, serial number (b)(4).The initial result was coi 1.49 (positive).The repeated results were coi 0.192 and coi 0.732 (both negative).The results were not reported outside of the laboratory.

Manufacturer Narrative

The customer tested the sample a fourth time and the result was negative.A numerical value for this repeated result was not provided.The customer believed the correct result to be negative.Based on the provided data/information a general reagent issue can 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: 10962162
• MDR Text Key: 226993033
• Report Number: 1823260-2020-03113
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 09203095190
• Device Lot Number: 51233901
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1