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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 Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2017
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 results for one patient. The patient had been moved from another hospital and the result for ca19-9 at that hospital using an architect analyzer had been 100 u/ml. The specific date of testing was unknown. The patient was then tested on cobas 8000 e 602 module serial number (b)(4) and the result was 30 u/ml. Information concerning if any erroneous result was reported outside the laboratory was requested but it was unknown. There was no allegation of an adverse event. Sample from the patient was submitted for investigation and tested on a roche analyzer. The result was 30. 87 u/ml. The same sample was sent to another laboratory for testing on an architect analyzer and the result was 124 u/ml. A specific root cause could not be determined as additional sample material was not available for further investigation. Based on the results of the testing, the root cause was possibly due to the difference in the reaction for the sugar chain's antigen. Interference in the sample was excluded based on the results from a neuraminidase test. Product labeling for the assay states that single ca 19-9 results from different assay formats must not be directly compared to each other, because different methods may report different results. In case of a change in method, several parallel measurements are highly recommended.
 
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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 Key6559299
MDR Text Key74902566
Report Number1823260-2017-00976
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
Report Date 05/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number11776193122
Device Lot Number16842400
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2017
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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