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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 04/14/2017
Event Type  malfunction  
Manufacturer Narrative
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. A possible cause was the use of different ca19-9 antibodies in the different manufacturer's assays as the different antibodies presumably recognize different parts of the molecule. It is known that the ca 19-9 results for a patient¿s sample can vary depending on the testing procedure used. Ca 19-9 values determined on patient samples by different testing procedures cannot be directly compared with one another. This information id documented in product labeling for the assay. There is no international standard available for ca19-9. A general reagent issue was excluded as the reagents used for investigation performed acceptably and no similar complaints have been reported.
 
Manufacturer Narrative
(b)(4). This event occurred in (b)(6).
 
Event Description
The customer received questionable elecsys ca 19-9 immunoassay results for one patient compared to the results they received from lumipulse analyzer. (b)(6). This sample was submitted for investigation and was tested on cobas 6000 e 601 module serial number (b)(4) on (b)(6) 2017. The results were 1. 56 u/ml and 1. 22 u/ml. The reagent lot in use for this testing was 193941 with expiration date 05/01/2018. The results were reported to the clinician. There was no allegation of an adverse event.
 
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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 Key6737251
MDR Text Key160879243
Report Number1823260-2017-01517
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 09/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number11776193122
Device Lot NumberASKU
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 Received07/04/2017
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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