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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS AFP ASSAY KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

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ROCHE DIAGNOSTICS ELECSYS AFP ASSAY KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER Back to Search Results
Model Number AFP
Device Problem Non Reproducible Results (4029)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The investigations found the issue was caused by the afp reagent pack. The follow up/corrective actions were the replacement of the reagent pack. 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 results were generated by the cobas e 411 immunoassay analyzer. The events involved a total of 2 patients with low results for the elecsys afp assay. The patients' ages were requested, but were not provided. The patients' weights were requested, but were not provided. The patients' genders were requested, but were not provided. The patients' races were requested, but were not provided. The patients' ethnicities were requested, but were not provided.
 
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Brand NameELECSYS AFP ASSAY
Type of DeviceKIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
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 Key8256689
MDR Text Key133503267
Report Number1823260-2019-90000
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberAFP
Device Lot Number31718
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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