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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 Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/08/2019
Event Type  malfunction  
Manufacturer Narrative
The event occurred in (b)(6).
 
Event Description
The initial reported complained of elecsys afp assay results for 1 patient from a cobas 6000 e 601 module that were not matching the patient's clinical picture. The initial afp result was >1000 iu/ml with a data flag. The patient sample was repeated using a 1:50 dilution and a result of 1329 iu/ml was obtained. A comparable result was also obtained for a siemens analyzer with an approximate afp result of 1800 iu/ml. The suspected high result was reported outside of the laboratory. There was no allegation of an adverse event. The customer believes these high results are not matching the patient's clinical finding as magnetic resonance imaging (mri) imaging was negative. The cobas e601 serial number was (b)(4). The investigation is currently ongoing.
 
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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 Key8569513
MDR Text Key143707357
Report Number1823260-2019-01615
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
K981282
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model NumberAFP
Device Catalogue Number04481798190
Device Lot Number34949001
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 Received04/09/2019
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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