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

Catalog Number 09203095190

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Other text : na.

Event Description

The initial reporter stated they were having issues with third party control recovery for the elecsys anti-sars-cov-2 assay on a cobas 6000 e 601 module.The issue started when new anti-sars-cov-2 reagent lot 56426000 was placed on board the analyzer on 09-aug-2021.Roche manufactured controls were provided to the customer and these recovered within range on 11-aug-2021.In order to troubleshoot the third party control issue, the customer pulled some patient samples that had been originally tested on (b)(6) 2021 and repeated these after the roche controls were tested on 11-aug-2021.The initial sample values from (b)(6) 2021 were believed to be correct.Of the repeated samples, three samples that were initially non-reactive, now recover with reactive values.No incorrect results were reported outside of the laboratory.The first sample initially resulted in an anti-sars-cov-2 value of 0.312 coi (non-reactive) on (b)(6) 2021.The sample was repeated on (b)(6) 2021, resulting in a value of 1.30 coi (reactive).The second sample initially resulted in an anti-sars-cov-2 value of 0.741 coi (non-reactive) on (b)(6) 2021.The sample was repeated on (b)(6) 2021, resulting in a value of 5.00 coi (reactive).The third sample initially resulted in an anti-sars-cov-2 value of 0.293 coi (non-reactive) on (b)(6) 2021.The sample was repeated on (b)(6) 2021, resulting in a value of 1.52 coi (reactive).The serial number of the e 601 analyzer is (b)(4).

Manufacturer Narrative

The customer's calibration results were ok.The customer's qc was recovering high.The negative qc material resulted in a reactive result.The investigation reviewed the system alarm trace and no abnormalities were found.The field service engineer performed system maintenance and replaced various parts.He performed performance testing and roche qc with acceptable results.The customer's third-party controls did not pass.After service, the customer did not respond to any follow-ups.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: 12367845
• MDR Text Key: 269524781
• Report Number: 1823260-2021-02471
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• PMA/PMN Number: EUA200514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 09203095190
• Device Lot Number: 56426000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1