MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 19-9; TEST, CARBOHYDRATE ANTIGEN (CA19-9)

Catalog Number 11776193122

Device Problem Low Test Results (2458)

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 19-9.Refer to medwatch with (b)(6) for information on the ca 15-3 ii 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 (b)(4).

Manufacturer Narrative

Based on the information provided, it was noted that if the patient belongs to the lewis a-negative/b-negative blood group, the ca 19-9 results may not be correct.A specific root cause could not be identified, however, it is known that different ca 19-9 assays can produce different results.This is covered in product labeling.It is also possible that there is an interference in the sample that could affect results when testing with different assays.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 19-9
• Type of Device: TEST, CARBOHYDRATE ANTIGEN (CA19-9)
• 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: 5514282
• MDR Text Key: 40803660
• Report Number: 1823260-2016-00336
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050231
• 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

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11776193122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2016
• 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