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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HELIX OPCO LLC. COVID-19 TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

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HELIX OPCO LLC. COVID-19 TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID Back to Search Results
Device Problem False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2021
Event Type  malfunction  
Event Description
Took a covid test at the same time and place as my boyfriend and roommates on (b)(6) 2021 and 3 came back negative but mine came back positive.Knew that couldn't be correct so went and got 2 more covid tests on (b)(6) 2021 and both came back negative.Fda safety report id # (b)(4).
 
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Brand Name
COVID-19 TEST
Type of Device
REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
Manufacturer (Section D)
HELIX OPCO LLC.
101 s. ellsworth ave suite 350
san mateo CA 94491
MDR Report Key11259965
MDR Text Key229846240
Report NumberMW5099100
Device Sequence Number1
Product Code QJR
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/29/2021
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age30 YR
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