• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS ELECSYS CA 19-9 IMMUNOASSAY TEST, CARBOHYDRATE ANTIGEN (CA19-9) Back to Search Results
Catalog Number 11776193122
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This event occurred in (b)(6).
 
Event Description
The customer received a questionable elecsys ca 19-9 immunoassay result for one patient from a cobas 8000 e 602 module serial number (b)(4). The result was 90 u/ml. The sample was tested in another laboratory on a unicel dxh800 (beckman coulter) analyzer and the access gi monitor ca19-9 result was 337. 00 u/ml. The customer was unsure which result was correct. Information concerning if any erroneous result was reported outside the laboratory was requested but it was unknown. The patient was not adversely affected.
 
Manufacturer Narrative
Sample from the patient was submitted for investigation and the customer's results on both the cobas e602 and beckman coulter analyzers were confirmed. The reason for the discrepancy could not be determined based upon the information provided for investigation, a general product problem was excluded. In general, it is known ca 19-9 values determined on patient sample by different testing procedures or different instruments cannot be directly compared to one another. Differences in results between methodologies may be due to the use of different antibodies, different antibody specificities, and different assay formats. In addition, there is no international standard available for ca 19-9.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameELECSYS CA 19-9 IMMUNOASSAY
Type of DeviceTEST, 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 Key6150704
MDR Text Key61606918
Report Number1823260-2016-01910
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K050231
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue Number11776193122
Device Lot Number164834
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 Received11/21/2016
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

-
-