MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CYFRA 21-1; CYTOKERATIN FRAGMENTS 21-1 EIA

Catalog Number 11820966122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter received questionable cyfra 21-1 elecsys results for 13 patient samples on a cobas e 411 immunoassay analyzer, serial number (b)(4).The results were reported outside of the laboratory.

Manufacturer Narrative

The investigation found that the lumipulse results and abbott architect results are comparable and the elecsys results were found to be higher.The results from the investigation indicated that the higher results for samples numbers 37 and 41 were recorded with the competitor assays as well.Product labeling states: "the measured cyfra 21-1 value of a patient¿s sample can vary depending on the testing procedure used.The laboratory finding must therefore always contain a statement on the cyfra 21-1 assay method used.Cyfra 21-1 values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.If there is a change in the cyfra 21-1 assay procedure used while monitoring therapy, then the cyfra 21-1 values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods." the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS CYFRA 21-1
• Type of Device: CYTOKERATIN FRAGMENTS 21-1 EIA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10727186
• MDR Text Key: 212846685
• Report Number: 1823260-2020-02631
• Device Sequence Number: 1
• Product Code: OVK
• Combination Product (y/n): N
• PMA/PMN Number: K160915
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11820966122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1