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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 07/27/2017
Event Type  malfunction  
Manufacturer Narrative
It was clarified that the erroneous results were not reported outside of the laboratory.
 
Manufacturer Narrative
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
 
Event Description
The customer complained of erroneous results for 1 patient sample tested for elecsys ca 19-9 immunoassay (ca 19-9) on a cobas e 411 immunoassay analyzer compared to the siemens advia centaur method. It is not known if erroneous results were reported outside of the laboratory. The patient sample was initially tested by the centaur method and the ca 19-9 result was 700 u/ml. After an automatic dilution of 1:100 the centaur analyzer produced a dilution error with no result. After performing a dilution of 1:200, the result from the centaur method was 668. 71 u/ml. The same patient sample was tested on the e411 analyzer and the ca 19-9 result was 7. 87 u/ml which is in the "normal" range. The sample was diluted by 1:20 and the result from the e411 analyzer was 21. 7 u/ml. The customer did not perform this dilution as instructed in product labeling. Product labeling states samples with ca 19-9 concentrations above the measuring range can be diluted. The recommended dilution is 1:10 either automatically or manually. The concentration of the diluted sample must be > 50 u/ml. There was no allegation that an adverse event occurred. The e411 analyzer serial number was (b)(4). The customer stated that calibration, quality controls and alarm trace data was all acceptable, however, no original data was provided for investigation. A specific root cause was not identified. The patient sample was requested for investigation but could not be provided. Based on the information provided, a general reagent issue was not identified. A general product problem has been excluded. The discrepancy between the centaur method and the e411 analyzer are due to different testing procedures such as the different antibodies used in different assays. Product labeling contains the following statement: the measured ca 19 9 value of a patient's sample can vary depending on the testing procedure used. The laboratory finding must therefore always contain a statement on the ca 19 9 assay method used. Ca 19 9 values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations. If there is a change in the ca 19 9 assay procedure used while monitoring therapy, then the ca 19 9 values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods.
 
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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 Key6803583
MDR Text Key246807105
Report Number1823260-2017-01753
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeRS
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 09/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2017
Device Catalogue Number11776193122
Device Lot Number133102
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2017
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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