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

Catalog Number 11820966122

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 07/01/2022

Event Type  malfunction  

Event Description

The initial reporter questioned high results not corresponding to the clinical picture for 1 patient tested for elecsys cyfra 21-1 (cyfra 21-1) on a cobas 6000 e 601 module.The initial result from the e601 module was 6.12 ng/ml.This result was reported outside of the laboratory.On (b)(6) 2022 the patient went to a different hospital where a new sample was drawn and the result by the elecsys method was 1.8 ng/ml.On (b)(6) 2022 the customer repeated the original sample on the e601 module and the result was 5.84 ng/ml.The customer sent the sample to two other hospitals where the results by the elecsys method on (b)(6) 2022 were 5.41 ng/ml and 5.02 ng/ml.An aliquot of the original sample was also sent to the same hospital where the patient had gone on (b)(6) 2022 and the result by the elecsys method was 4.73 ng/ml.The customer thinks the results should be lower as all the other tumor marker results for the patient were normal.The e601 module serial number was (b)(4).

Manufacturer Narrative

Medwatch field d4, expiration date was updated.Calibration and qc were acceptable.Sample material was requested for investigation but was not provided.As the sample was not available for investigation, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15177401
• MDR Text Key: 305266800
• Report Number: 1823260-2022-02312
• Device Sequence Number: 1
• Product Code: OVK
• Combination Product (y/n): N
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 11820966122
• Device Lot Number: 55188502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• 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: 67 YR
• Patient Sex: Female