MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 15-3 II ASSAY; TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 03045838122

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer received a questionable low elecsys ca 15-3 ii assay result for one patient sample from a cobas 8000 e 602 module.The serial number was requested but was not provided.The result was 32.9 ui/ml and was reported outside of the laboratory.The result from a beckman analyzer was 205 ui/ml.There was no allegation of an adverse event.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.Based on provided data and information, an assay related issue was not found.

• Brand Name: ELECSYS CA 15-3 II ASSAY
• Type of Device: TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM
• 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: 7270367
• MDR Text Key: 100282730
• Report Number: 1823260-2018-00437
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K010588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03045838122
• Device Lot Number: 20990000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1