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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOMAL DNA TEST AUTOSOMAL RECESSIVE CARRIER SCREENING GENE MUTATION DETECTION SYSTEM

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AUTOSOMAL DNA TEST AUTOSOMAL RECESSIVE CARRIER SCREENING GENE MUTATION DETECTION SYSTEM Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Insufficient Information (4580)
Event Date 02/09/2019
Event Type  Injury  
Event Description
Reporter stated he had a dna test done using the autosomal dna test at (b)(6) and believed the test is fake. He also believed it is not a real test, done through the courts by (b)(6). Reporter stated that (b)(6) claims that a mother's dna is optional (in (b)(6) website) but three variables are required for the dna autosomal test; the mother, the child, and the prospective father. (b)(6) is only testing the child and father and not using the mother's dna, which is not how an autosomal test is done.
 
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Brand NameAUTOSOMAL DNA TEST
Type of DeviceAUTOSOMAL RECESSIVE CARRIER SCREENING GENE MUTATION DETECTION SYSTEM
MDR Report Key10801147
MDR Text Key215309979
Report NumberMW5097692
Device Sequence Number1
Product Code PKB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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?
Type of Device Usage

Patient Treatment Data
Date Received: 11/05/2020 Patient Sequence Number: 1
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