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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 04481798190
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This event occurred in (b)(6).
 
Event Description
The customer complained of questionable high elecsys afp assay (afp) results for multiple patient samples on a cobas e 411 immunoassay analyzer serial number (b)(4). The customer stated that "every 10th-20th" sample with afp results 8-18 iu/ml were less than 5 iu/ml with a siemens immulite 2000 method. The customer provided data for 14 patient samples with erroneous afp results when compared to the siemens immulite 2000 method. The customer stated that most of the patients were males but did not provide the specific gender for each result. Refer to the attachment to this medwatch for all of the patient data. The erroneous results were reported outside of the laboratory however the physician was informed of the afp results with the siemens immulite 2000 method. There was no allegation of an adverse event. The customer poured the samples into eppendorf tubes and tested with "cup on tube". The customer did not have issues with other hormone tests.
 
Manufacturer Narrative
The investigation was unable to find a definitive root cause.
 
Manufacturer Narrative
There were 14 samples provided for investigation. The customer's afp results with a cobas e 411 immunoassay analyzer were reproducible. The investigation is 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 Key7381892
MDR Text Key104138880
Report Number1823260-2018-00954
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number04481798190
Device Lot Number00300107
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 Received03/12/2018
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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