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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 Consequences Or Impact To Patient (2199)
Event Date 08/01/2016
Event Type  malfunction  
Event Description
The customer stated that they received erroneous results for an unspecified number of samples from the same patient tested for the elecsys afp assay on a cobas 6000 e 601 module. The specific date of the event is not known. The customer stated that over a two year period, multiple samples from the patient recovered high afp results ranging between 761 and 1028 ng/ml when tested with multiple lots of the roche assay. When tested with the abbott and beckman coulter assays, the patient also had high values. The wako and siemens immulite platforms, however, yielded results from the patient which were within their respective normal reference ranges. The customer does not know which values are correct, but believes the high values to be in error. The customer suspects that samples from the patient contain an interferent to a component of the roche afp assay. The patient was not taking high levels of biotin. The customer provided data for two specific samples from the patient. No specific testing dates were provided for the two samples. The customer stated that the patient was last tested 2 to 3 months prior to (b)(6) 2018. The first sample resulted as 761 ng/ml when tested on the e601 analyzer. The value was reported outside of the laboratory and questioned by the doctor. The sample was sent to another laboratory for confirmation testing on the siemens immulite analyzer and the result was 3. 42 ng/ml, which was within the normal range of that assay. The customer then sent the patient sample to other laboratories for testing on additional platforms. The sample resulted with values of 1. 2 ng/ml and 3. 2 ng/ml when tested on the wako platform. When tested on an abbott system, the sample recovered 802 ng/ml, which is considered high. The sample also recovered a high value of 1162 ng/ml when tested on the beckman platform. The first sample was also aliquoted and the customer ran a dilution series on the customer's e601 analyzer using this aliquot. The sample was tested without dilution, resulting as 778. 4 ng/ml. A 1:1 dilution yielded a result of 355. 9 ng/ml. A 1:2 dilution of the sample yielded a result of 214. 2 ng/ml. A 1:4 dilution of the sample yielded a result of 124. 4 ng/ml. A 1:9 dilution of the sample yielded a result of 58. 41 ng/ml. A 1:1 dilution of the sample with mouse serum yielded a result of 337. 1. A second sample from the patient resulted as 938 ng/ml when tested on the e601 analyzer. The sample was treated with a heterophilic antibody blocking tube from scantibodies and then tested on the e601 analyzer, resulting with a value of 970 ng/ml. The patient was not adversely affected. The serial number of the e601 analyzer is (b)(4).
 
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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 Key7822221
MDR Text Key118555952
Report Number1823260-2018-02897
Device Sequence Number1
Product Code LOJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981282
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04481798190
Device Lot NumberASKU
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 Received08/08/2018
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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