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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ONCOBLOT LABS ONCOBLOT LABS TEST; CANCER TEST
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ONCOBLOT LABS ONCOBLOT LABS TEST; CANCER TEST Back to Search Results
Device Problem False Positive Result (1227)
Patient Problem Emotional Changes (1831)
Event Date 03/08/2016
Event Type  Injury  
Event Description
This is regarding the oncoblot blood test which is currently seeking fda approval with a 510 (k) being prepared for submission.The website for this blood test is (b)(6).Through my primary care physician, dr.(b)(6), with the (b)(6) clinic in (b)(6), i had this blood test done.The results showed that i have proteins evident for breast cancer.I received these test results from dr.(b)(6) on (b)(6) 2016.On (b)(6) 2016, i had a breast mri with contrast done at (b)(6) medical center in (b)(6).The radiologist, dr.(b)(6), found no breast cancer.On (b)(6) 2016, i had a left breast biopsy done under general anesthesia at (b)(6) hospital in (b)(6).My surgeon's name was dr.(b)(6).The biopsy was done on the left breast as i did palpate a mass there, however, this mass was noted to not be cancer according to dr.(b)(6), the radiologist who read my mri.The pathology results of the breast biopsy was, like the mri, negative for cancer.I'm writing to report oncoblot labs to the fda for administering a blood test that rendered a (b)(6) result, and such, caused me much emotional anguish and monetary expense.
 
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Brand Name
ONCOBLOT LABS TEST
Type of Device
CANCER TEST
Manufacturer (Section D)
ONCOBLOT LABS
MDR Report Key5728711
MDR Text Key47630230
Report NumberMW5062882
Device Sequence Number0
Product Code OQS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/13/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age48 YR
Patient Weight53
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