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

Catalog Number 09289267190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2021

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys anti-sars-cov-2 s on a cobas 6000 e 601 module.The sample initially resulted in an anti-sars-cov-2 s value of < 0.400 u/ml (non-reactive) accompanied by a data flag.This initial value was reported outside of the laboratory.The user noticed a strange pattern in quality control recovery that occurred a few days prior to initial testing.Control recovery during this time dropped but was still within specifications.This prompted the initial reporter to rerun the sample on (b)(6) 2021.This sample resulted in a value of > 250.0 u/ml (reactive) accompanied by a data flag.The anti-sars-cov-2 s reagent lot number was 54861700, with an expiration date of 31-dec-2021.

Manufacturer Narrative

From the provided calibration data, the last calibrations performed on 28-jun-2021 and 02-aug-2021 were within expected ranges.Product labeling recommends the following calibration frequencies: after 31 days when using the same reagent lot; after 14 days when using the same reagent kit on the analyzer; as required: e.G quality control findings outside the defined limits.Quality controls were within range on 31-jul-2021 and 02-aug-2021.Upon review of the alarm trace, no relevant alarms were observed on 31-jul-2021 or 12-aug-2021.The field service engineer replaced the sample probe, pinch tube, and cells.A calibration of the probe liquid level detection was performed.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-SARS-COV-2 S
• Type of Device: CORONAVIRUS SEROLOGICAL REAGENT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12324247
• MDR Text Key: 266671420
• Report Number: 1823260-2021-02383
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• PMA/PMN Number: EUA202698
• 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: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09289267190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1