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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  malfunction  

Event Description

We received an allegation about discrepant results for 2 patients' samples tested with elecsys cyfra 21-1 assay on a cobas 6000 e601 immunoassay analyzer when compared to a non-roche (mindray) analyzer.Sample 1 (patient 1): initial result: 6.6 ng/ml.Repeat result: 3.58 ng/ml (tested on mindray).Sample 2 (patient 2): initial result: 6.4 ng/ml.Repeat result: 3.72 ng/ml (tested on mindray).The customer questioned the initial results.No questionable results were reported outside the laboratory and the samples were repeated on (b)(6) 2024.

Manufacturer Narrative

The e601 module serial number was (b)(6).Qc was acceptable but the calibration was not acceptable.The measuring cell has been used for about 2 years.The investigation is ongoing.

Manufacturer Narrative

The sample was requested for investigation but not provided.The instrument data showed no flags or alarms.A general reagent issue can be excluded.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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19053800
• MDR Text Key: 339555481
• Report Number: 1823260-2024-01054
• Device Sequence Number: 1
• Product Code: OVK
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K160915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 711310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/23/2024
• 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
• Patient Age: 66 YR
• Patient Sex: Male