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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
Catalog Number 04491742190
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/09/2017
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
 
Event Description
The customer complained of erroneous results for 2 patient samples tested for elecsys afp assay (afp) that were accompanied by a
 
Manufacturer Narrative
A specific root cause was not identified. Additional information was requested for investigation but was not provided. A general product problem can be excluded. Possible root causes for this event may be sample quality and insufficient maintenance.
 
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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 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 Key6404349
MDR Text Key69952885
Report Number1823260-2017-00559
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K981282
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 04/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04491742190
Device Lot Number176747
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 Received02/28/2017
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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