MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CYTOKERATIN FRAGMENTS 21-1 EIA KIT; TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM.

Catalog Number 11820966160

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The field service engineer did not identify a product problem.He recommended the customer use a new reagent cassette and perform calibration and qc with fresh materials.The field applications specialist performed a precision check.

Event Description

The initial reporter received questionable cyfra 21-1 elecsys results for one patient on a cobas e411 rack serial number (b)(4) and a cobas 8000 e 801 module, serial number requested but not provided.The initial results from an e411 were not reported outside the laboratory.The customer sent the patient¿s sample to another laboratory for repeat testing on an e 801.

Manufacturer Narrative

Qc results do not indicate a reagent issue.The customer could not provide the patient's sample for further testing to complete the investigation.The investigation did not identify a product or instrument problem.The cause of the event could not be determined.

• Brand Name: CYTOKERATIN FRAGMENTS 21-1 EIA KIT
• Type of Device: TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM.
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9878349
• MDR Text Key: 203516558
• Report Number: 1823260-2020-00838
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 11820966160
• Device Lot Number: 422890
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/26/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1