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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 High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6).
 
Event Description
The customer received a questionable high elecsys afp assay result for one patient sample from cobas 8000 (e602) serial number (b)(4). The initial result with a dilution was 1,603,000 ng/ml. The result from a centaur analyzer was 800 ng/ml. The sample was submitted for investigation as the customer suspected a nonspecific reaction. With an unknown roche analyzer, the high result was reproduced at 991,700 ng/ml with a 1:1000 dilution. The results with lumipulse and fuji-rebio methods were >50,000 ng/ml. Information concerning if any erroneous result was reported outside the laboratory was requested but it was unknown. The patient was not adversely affected.
 
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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 Key6088832
MDR Text Key59459903
Report Number1823260-2016-01750
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 11/09/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2017
Device Catalogue Number04491742190
Device Lot Number120174
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2016
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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