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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SARS-COR-2RT-QPCR; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
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SARS-COR-2RT-QPCR; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Spontaneous Abortion (4514)
Event Date 05/03/2021
Event Type  Injury  
Event Description
The u.S.Food and drug administration (fda) is warning the public to stop using the innova medical group sars-cov-2 antigen rapid qualitative test for diagnostic use.The fda has significant concerns that the performance of the test has not been adequately established, presenting a risk to health.In addition to this result prior to me having the sars-cor-2 rt-qpcr test administered to me in (b)(6) 2021 i had an successful ultrasound confirming the records of an fetus with a strong heart beat and in correct position of the placenta having to be a successful growing size to support my (b)(6) pregnancy.I have medical documentation to support the mentioned ultrasound date.Eight days after have taken the nasal test mentioned above on the date of (b)(6) i was rushed to the (b)(6) for medical treatment in response to a spontaneous miscarriage.Medical documentation to support this accident is available for your records.I anticipate a response to my matter in a timely order.Yours truly (b)(6).Fda safety report id # (b)(4).
 
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Brand Name
SARS-COR-2RT-QPCR
Type of Device
REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
MDR Report Key12421241
MDR Text Key270109332
Report NumberMW5103691
Device Sequence Number1
Product Code QJR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly; Hospitalization;
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