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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN AUTOSMAL DNA TEST FOPR PARENTAGE AUTOSOMAL RECESSIVE CARRIER SCREENING GENE MUTATION DETECTION SYSTEM

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UNKNOWN AUTOSMAL DNA TEST FOPR PARENTAGE AUTOSOMAL RECESSIVE CARRIER SCREENING GENE MUTATION DETECTION SYSTEM Back to Search Results
Model Number AUTSOMAL DNA TEST
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Cognitive Changes (2551)
Event Date 02/09/2019
Event Type  Injury  
Event Description
I was injured by a test. There is not a word in the english language for what is taking place. This test is sold in two different markets. One is the courts and the other is consumer (b)(6). In both venues, i received the court venue test which is conducted in a (b)(6) office. This test is claimed to be biological and scientific. This test is so dangerous. Please remove it from commerce. A corporation and scientist were caught red handed misstating not only science but also an accreditation claim. The phony accreditation claim had the effect of validating and otherwise invalid test, for many years. This test and all that went, into hiding this charade caused a serious decay in my ability to interpret labs results for myself. This was unfortunate because i needed emergency surgery which was delayed because i could not ascertain whether these reports about so called melanoma cancer were part of another scientific fraud or not. There is also a shocking phony accreditation claim. The science requires maternal dna in an autosomal dna analysis: my name is (b)(6). I am seriously injured by this conduct. Do you recall (b)(6)? (b)(6) looks like a combination of all 3. (b)(6) "sold " exclusionary parentage tests which have no ability to exclude men. (b)(6) tests made liars out of 100% of the men who took them and denied they slept with the mother. (b)(6) created criminal civil administrative and quasigovernmental liability with one $(b)(6) phony test. (b)(6) used malpractice insurance in connection with the sale of these autosomal tests and delivered tests which violated the contact (b)(6) acquired more liability than it has equity via its contractual agreements for parentage analysis. Their (b)(6) used malpractice insurance used in connection with the sale of an autosomal parentage test where the rosetta stone; maternal dna is not actually used in any autosomal dna analysis performed by (b)(6) which defies science. ? the test (b)(6) pretends to use does not exist in science. The test is in fact only a form and lacks any binary mechanism. The word "test" used to describe these forms is misleading. (b)(6) used the money, it made on selling paper and created an illusion. It made money through real business. Under (b)(6), (b)(6) sold a material amount of autosomal dna tests missing the rosetta stone, the maternal dna which were also insured. (b)(6) is on his way out though still using the plane and receiving a $(b)(6) a year plus a full release from his conduct after getting caught lying about an accreditation. The science "if the alleles of the biologic mother cannot be determined and her obligate alleles cannot be identified in the child, then the biologic father's obligate alleles cannot be deduced. " testing for parentage, robert e. Wenk, hematology (2004) 11:357¿361 science according to labcorp: maternal dna isn't necessary in autosomal dna analysis. Fda safety report id # (b)(4).
 
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Brand NameAUTOSMAL DNA TEST FOPR PARENTAGE
Type of DeviceAUTOSOMAL RECESSIVE CARRIER SCREENING GENE MUTATION DETECTION SYSTEM
Manufacturer (Section D)
UNKNOWN
MDR Report Key10816664
MDR Text Key216345923
Report NumberMW5097768
Device Sequence Number1
Product Code PKB
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
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 Received11/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberAUTSOMAL DNA TEST
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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: 11/09/2020 Patient Sequence Number: 1
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