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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 15-3 II ASSAY; TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM

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ROCHE DIAGNOSTICS ELECSYS CA 15-3 II ASSAY; TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM Back to Search Results
Catalog Number 03045838122
Device Problem High Test Results (2457)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/09/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).This event occurred in (b)(6).
 
Event Description
The customer received questionable high ca 15-3 results for two patient samples where various scans on the patients were negative.Of the data provided, only one patient was tested with the elecsys ca 15-3 ii assay.The patient had breast cancer in 2010 treated by surgery, radiotherapy, and hormone therapy and was monitored for ca 15-3 using the kryptor-brahms method.On (b)(6) 2015, the ca 15-3 result was 30.9 ku /l.The breast mri was normal and the patient was well.On (b)(6) 2015, the ca 15-3 result was 32.8 ku /l.In (b)(6) 2015, the patient had a tep that was a normal scan.On (b)(6) 2016, the ca 15-3 result was 97.8 ku /l, which triggered a new pet scan that showed nothing.In (b)(6) 2017, the patient had a bone scintigraphy with nothing to report.On (b)(6) 2017, the ca 15-3 result was 260.5 ku /l.As the ca 15-3 results increased but many imaging tests were negative, the customer suspected interference.Dilutions of the samples were performed and did not change the results.On (b)(6) 2017, two of the samples were repeated using the elecsys ca 15-3 ii assay and a cobas 6000 e 601 module.The serial number of the analyzer was requested, but it was not provided.The sample from (b)(6) 2017 had a result of 300.0 ku/l with a data flag and 280.1 ku/l with a 1:10 dilution.The sample from (b)(6) 2016 had a result of 113.4 ku/l and 111.2 ku/l with a 1:10 dilution.Testing using an hbt tube was negative.The presence of rheumatoid factors (igm and iga) was found to be negative.All of the results were reported outside the laboratory.There was no allegation of an adverse event.
 
Manufacturer Narrative
Samples from the patient were submitted for investigation.No interference could be detected in the samples.The results obtained by the customer were considered to be correct and no general reagent issue was suspected.
 
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Brand Name
ELECSYS CA 15-3 II ASSAY
Type of Device
TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM
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 Key6622157
MDR Text Key77420875
Report Number1823260-2017-01178
Device Sequence Number1
Product Code MOI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K010588
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 07/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03045838122
Device Lot Number192171
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/23/2017
Initial Date FDA Received06/08/2017
Supplement Dates Manufacturer Received05/23/2017
Supplement Dates FDA Received07/25/2017
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 N
Patient Sequence Number1
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