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

Catalog Number 09289267190

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

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

Event Date 02/27/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) # (b)(4).The country of origin is (b)(6).The most recent qc results provided were from (b)(6) 2021.No qc results were provided on the date of the event.As indicated in the method sheet, "calibration must be performed once per reagent lot using fresh reagent (i.E.Not more than 24 hours since the same reagent kit was registered on the analyzer).Calibration interval may be extended based on acceptable verification of calibration by the laboratory.Renewed calibration is recommended as follows: after 31 days when using the same reagent lot on the cobas e 411, cobas e 601 and cobas e 602 analyzers" the field service engineer performed preventive actions and adjustments which included sample probe adjustment.The customer has not had any further issues.A general reagent issue can most likely be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter stated they received discrepant results for one patient tested with the elecsys anti-sars-cov-2 s assay on a cobas 6000 e 601 module serial number (b)(4).The initial result was 0.400 u/ml with a data flag.The result was reported outside the laboratory and the result was questioned by the clinic.On (b)(6) 2021 the repeat result was 250 u/ml with a data flag.

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11563302
• MDR Text Key: 244484112
• Report Number: 1823260-2021-00906
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: EUA202698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 09289267190
• Device Lot Number: 51639401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1