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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
Model Number CA 19-9
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigations confirmed the customer's results. The investigation did not identify a product problem. The cause of the event could not be determined. No devices were returned. This device is not labeled for single use and is not reprocessed or reused.
 
Event Description
This report summarizes 1 malfunction events. Erroneous low elecsys ca 19-9 immunoassay results were generated by the cobas 8000 e 602 module. The events involved one patient. The patient's age was requested but was not provided. The patient's weight was requested but was not provided. The patient's gender was requested but was not provided. The patient's race was requested but was not provided. The patient's ethnicity was requested but was not provided.
 
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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
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhofferstrasse 116
na
mannheim (baden-wurttemberg), na 68305
GM 68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key8284312
MDR Text Key134752740
Report Number1823260-2019-90021
Device Sequence Number1
Product Code NIG
UDI-Device Identifier04015630904297
UDI-Public04015630904297
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberCA 19-9
Device Catalogue Number11776193122
Device Lot NumberASKU
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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