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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 Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/25/2017
Event Type  malfunction  
Manufacturer Narrative
A specific root cause could not be identified. The investigation stated the measured afp value of a patient's sample can vary depending on the testing procedure used. Afp values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations. This information is documented in product labeling for the assay.
 
Manufacturer Narrative
This event occurred in (b)(6). (b)(4).
 
Event Description
The customer complained of erroneous results for 1 patient sample tested for elecsys afp assay (afp) on a cobas 8000 e 602 module. The initial afp result from the e602 module was 15. 0 ng/ml. This result was reported outside of the laboratory. The sample was sent to an external laboratory and repeated using the ligand binding assay method from wako and the result was 5. 7 ng/ml. The customer does not known which result is correct. There was no allegation that an adverse event occurred. The e602 module serial number was not provided.
 
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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 Key6940687
MDR Text Key250478379
Report Number1823260-2017-02269
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 10/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2017
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 Received09/25/2017
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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