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

Catalog Number 09203095190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

The customer performed quality controls.The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter received questionable positive anti-sars-cov-2 elecsys results for two patient samples from the cobas 6000 e601 module serial number (b)(4).A sample from (b)(6) 2020 had a result of coi= 3.72 (reactive).The "quick test" result was negative for igm and igg.A sample from (b)(6) 2020 had a result of coi= 4.56 (reactive).The "quick test" result was negative for igm and igg.The questionable results were not reported outside of the laboratory.It is unknown which result was consider to be correct.The "quick test" does not have eua (emergency use authorization) approval.No pcr testing was performed on the patient.

Manufacturer Narrative

2 samples were requested for investigation.The investigation reproduced the customer¿s results and the samples are clearly reactive on elecsys anti-sars-cov-2.The appearance of discrepant reactive results is rare (<0.2% of all samples) but to be expected for a serological assay.The sample has been tested and confirmed negative in a rapid assay and another independent, roche in-house sars-antibody assay.Further clarification of the observed discrepancies is not possible with available methods and the current state of the art.

• 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: 10200356
• MDR Text Key: 200799852
• Report Number: 1823260-2020-01552
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• 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: 494813
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1