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U.S. Department of Health and Human Services

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

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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 09/07/2016
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). (b)(4). (b)(6).
 
Event Description
The customer stated that they received erroneous results for two samples from the same patient tested for the elecsys ca 19-9 immunoassay (ca19-9) on an e601 analyzer. When compared to a result from the siemens method, it was stated that the siemens result better fits with the medical history of the patient. All e601 analyzer results were forwarded to a physician and these results were questioned. The first sample tested on the e601 analyzer resulted as 3. 7 u/ml (reference range is < 34 u/ml). A second sample from the patient was tested after (b)(6) 2016, but before (b)(6) 2016, resulting as approximately 200 u/ml using the siemens method. It was stated that the reference range for the siemens ca19-9 method is similar to that of the roche ca19-9 method. A third sample from the patient was tested on the e601 analyzer on (b)(6) 2016, resulting as 30. 5 u/ml (reference range is < 34 u/ml). The patient was not adversely affected. The e601 analyzer serial number is (b)(4). The customer was informed that the ca19-9 result as determined by assays from different manufacturers can vary due to differences in methodology. The customer questions the specificity and sensitivity of the roche assay.
 
Manufacturer Narrative
A sample from the patient was provided for investigation. Investigations confirmed that the sample recovered below the reference range of the ca19-9 assay. The sample did not show any evidence for a false low result due to high dose hook effect or specific interferences. Based on investigation measurements, the results obtained by the customer are regarded to be true ca19-9 results. The lower measurements obtained by the customer may be caused by instability of the antigen due to transport or storage conditions. It is also known, that due to the complex nature of the ca19-9 antigen, ca19-9 results can differ significantly between different methods, caused by different reaction conditions in the different methods.
 
Manufacturer Narrative
During investigations, measurements of the provided samples were performed on a centaur system, confirming the roche test results for ca 19-9, ca 125 and cea.
 
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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 Key6075338
MDR Text Key59123783
Report Number1823260-2016-01718
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 01/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received10/20/2016
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

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