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

Catalog Number 09203095190

Device Problems False Negative Result (1225); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Phone number was provided as (b)(6).

Event Description

The initial reporter stated they received a discrepant result for one patient sample tested with the elecsys anti-sars-cov-2 assay on a cobas 8000 e 602 module.The sample initially resulted with an elecsys anti-sars-cov-2 value of 0.147 coi (non-reactive) and this value was reported outside of the laboratory to the physician.The physician questioned the value since the patient had an earlier anti-sars-cov-2 positive result.The sample was repeated on (b)(6) 2020, resulting with a value of 1.30 coi (reactive).This value was considered to be correct.The e 602 analyzer serial number is (b)(4).

Manufacturer Narrative

Calibration and control results were acceptable.Upon review of the alarm trace, several alarms related to sample volume and abnormal sample aspiration occurred.The investigation could 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: 10451556
• MDR Text Key: 204432588
• Report Number: 1823260-2020-02103
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• 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: 495464
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR