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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INNERGY DEPARTMENT AO SCAN DIGITAL BODY ANALYZER

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INNERGY DEPARTMENT AO SCAN DIGITAL BODY ANALYZER Back to Search Results
Device Problem False Positive Result (1227)
Patient Problem Misdiagnosis (2159)
Event Date 12/01/2017
Event Type  malfunction  
Event Description
I am concerned that the ao scan, product of innergy development (b)(6) is being used as a diagnostic testing product without fda regulation. Patient presented to my office on (b)(6) 2017 with report of ao scan. Patient was concerned that this test said she had a (b)(6) result for (b)(6). She provided me a copy of the 24 page report provided to her from this scan. This report contains an extensive list of medical diseases and biomarkers and designates a positive or negative or normal or abnormal result for each. Additional tests identified as abnormal for my patient which made her concerned included bartonella, (b)(6), low glutathione, high blood viscosity, cerebral arteriosclerosis, rdw, adrenal medulla, pancreas, pituitary, acanthamoeba, racoon roundworm, and scabies. I expressed my concerns about the validity of this test to my patient and ordered reliable (b)(6) testing for her which was (b)(6). Page 24 of the report contains a disclaimer "it is not a diagnostic tool and cannot diagnose or treat any condition or disease. " however, it is generally accepted that telling a patient they have a positive or negative result for a test for a disease is equivalent to diagnosing a disease, and this should be regulated by the fda. Further evidence that the device is functioning as a diagnostic test is found on the (b)(4) where they claim greater accuracy than convention diagnostic methods of ultrasound, ct, or mri for diseases listed in a chart.
 
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Brand NameAO SCAN
Type of DeviceDIGITAL BODY ANALYZER
Manufacturer (Section D)
INNERGY DEPARTMENT
orem UT 84058
MDR Report Key7100862
MDR Text Key95067078
Report NumberMW5073841
Device Sequence Number1
Product Code MNW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2017
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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