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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 10/29/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This event occurred in (b)(6).
 
Event Description
The customer received questionable low elecsys afp assay results for one patient sample from cobas e602 analyzer serial number (b)(4). The results were 1. 93 ng/ml, 6. 00 ng/ml with a 1:10 dilution, and 2. 02 ng/ml as the previous result for the patient had been about 10,000 ng/ml, the customer tested another sample from the patient drawn at the same time as the suspect sample and the result was about 10,000 ng/ml. Information concerning if any result was reported outside the laboratory was requested, but it was unknown. The patient was not adversely affected.
 
Manufacturer Narrative
As part of the investigation, the sample from the patient that generated the result 2. 02 ng/ml of was tested and the customer's result was reproduced. Elecsys: 1. 83 ng/ml, lumipulse: 2. 2 ng/ml. Based on the data available, a specific root cause could not be determined. The sample does not have a non-specific reaction or prozone phenomenon. Additional sample was not available for further testing.
 
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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 Key6090305
MDR Text Key59577563
Report Number1823260-2016-01752
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,Followup
Report Date 12/06/2016
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 Catalogue Number04491742190
Device Lot Number120174
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 Received10/31/2016
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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