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 Consequences Or Impact To Patient (2199)

Event Date 05/27/2016

Event Type  malfunction  

Event Description

The customer stated that they received erroneous results for one patient sample tested for carbohydrate antigen 19-9 (b)(4) on an e170 analyzer. The results from the e170 analyzer were reported outside of the laboratory and were questioned by a doctor. The sample initially resulted as 262 u/ml on the e170 analyzer. The sample was tested on an architect analyzer, resulting as 3354 u/ml. The sample was repeated on (b)(6) 2016, resulting as 276 u/ml on the e170 analyzer. The sample was also repeated on the architect analyzer on (b)(6) 2016, resulting as 3350 u/ml. The results from the architect analyzer were believed to be correct. The patient was not adversely affected. The e170 analyzer serial number was (b)(4). The field service representative ran performance testing.

Manufacturer Narrative

Investigations conclude that ca 19-9 values can vary when measuring the same sample with different methods. This limitation is covered in product labeling.

• 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: 5741144
• MDR Text Key: 47909247
• Report Number: 1823260-2016-00793
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 11776193122
• Device Lot Number: 18863203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/01/2016
• 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

Patient Treatment Data

Date Received: 06/22/2016 Patient Sequence Number: 1

Treatment

METFORMIN (GLUCOPHAGE)