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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS ELECSYS CA 19-9 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 04/26/2016
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).
 
Event Description
The customer received questionable carbohydrate antigen 19-9 results for one patient when compared to other platforms. The data provided for the patient was: during a medical checkup, the result was "the upper normal range". In "bio medika", the result was 30. 96 u/ml. In lab 1 with a cobas e601 analyzer, the result was 32 u/ml. The patient was checked again and the result on a siemens analyzer was 62 u/ml. In lab 2 with a cobas e601 analyzer, the result was 27 u/ml. In another laboratory with an unknown analyzer, the result was 53. 5 u/ml. Information regarding if all of the results were from the same sample was requested, but was not provided. Information regarding if any erroneous results was reported outside the laboratory or if the patient was adversely affected was requested, but was not provided. The serial number (b)(4) was provided, but it was not clear which cobas e601 this was. The serial number of the other cobas e601 was requested, but was not provided.
 
Manufacturer Narrative
Additional information was provided that the results from the different labs were tested from different sample tubes drawn from the same patient on different dates. The testing was performed in different counties such as (b)(4). For the result from "(b)(4)", a cobas e 601 analyzer was used. The customer is unclear as to which result is correct.
 
Manufacturer Narrative
A specific root cause could not be identified. Based on the provided, the results between roche analyzers were stable and comparable. Review of the provided calibration and qc data did not indicate any analyzer or reagent issue. Ca 19-9 results can vary when the same sample is tested with different assays from different manufacturer's and cannot be directly compared with one another. This difference is documented in product labeling. It is recommended to continue with one method for monitoring of the patient, or running several parallel measurements with the same sample on the different methods to confirm if the differences between the methods remain stable.
 
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Brand NameELECSYS CA 19-9
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 Key5673221
MDR Text Key45704405
Report Number1823260-2016-00677
Device Sequence Number1
Product Code NIG
Combination Product (y/n)N
Reporter Country CodeID
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 06/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2017
Device Catalogue Number11776193122
Device Lot Number18863203
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2016
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

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