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

Catalog Number 11776193122

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable carbohydrate antigen 19-9 (ca 19-9) results for one patient sample from an analytical e module analyzer. The initial result was >1000 ng/ml. The sample was repeated with a 1:10 dilution and the result was 175. 9 ng/ml. The sample was repeated with a 1:100 dilution and the result was 105. 3 ng/ml. The sample was submitted for investigation. The result from a cobas e411 analyzer was 865. 7 u/ml. The result from a lumipulse analyzer was 219 u/ml. The sample was tested for linearity and the results were: undiluted: >1000 u/ml 1:2: 865. 7 u/ml 1:5: 233. 1 u/ml 1:10: 106. 3 u/ml it was unknown if any results were reported outside the laboratory. There was no adverse event. Based on these results, interference was suspected in the sample. As no further sample material was available, a specific root cause could not be determined.

• 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: 5457624
• MDR Text Key: 38998837
• Report Number: 1823260-2016-00212
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 11776193122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/05/2016
• 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