MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 15-3; TEST, CANCER ANTIGEN (CA 15-3 II)

Catalog Number 03045838122

Device Problem High Test Results (2457)

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

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient sample tested for cancer antigen 15-3 (ca 15-3 ii) and carbohydrate antigen 19-9 (ca 19-9).The erroneous results were reported outside of the laboratory.This medwatch will cover ca 15-3 ii.Refer to medwatch with (b)(6) for information on the ca 19-9 erroneous results.The initial ca 15-3 result from the e601 analyzer was 289.4 u/ml.The sample was repeated on the e601 analyzer on (b)(6) 2016 and the result was 276 u/ml.The sample was repeated at a different laboratory on an abbott instrument and the result was 193.7 (unit of measure not provided).The initial ca 19-9 result from the e601 analyzer was 393.54 u/ml.The sample was repeated on the e601 analyzer on (b)(6) 2016 and the result was 391.7 u/ml.The sample was repeated at a different laboratory on an abbott instrument and the result was 962.3 (unit of measure not provided).It is not known if an adverse event occurred.No adverse event was reported.The e601 analyzer serial number was (b)(4).

Manufacturer Narrative

A specific root cause could not be identified.It was noted that the customer now believes that the roche results were correct based on an external quality survey that produced optimal results.No further information will be provided by the customer.

• Brand Name: ELECSYS CA 15-3
• Type of Device: TEST, CANCER ANTIGEN (CA 15-3 II)
• 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: 5514280
• MDR Text Key: 41059727
• Report Number: 1823260-2016-00335
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/13/2016

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: 03045838122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2016
• 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