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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDEL CORP. QUIDEL CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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QUIDEL CORP. QUIDEL CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Fever (1858)
Event Date 03/15/2021
Event Type  malfunction  
Event Description
My partner took a covid-19 test that showed she was negative. However, she is showing symptoms including a three day fever and is living in the same apartment as me. Who has tested positive for covid and i also am showing all of the symptoms. Fda safety report id # (b)(4).
 
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Brand NameQUIDEL
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
QUIDEL CORP.
MDR Report Key11514731
MDR Text Key241065963
Report NumberMW5100075
Device Sequence Number1
Product Code QKP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 03/17/2021 Patient Sequence Number: 1
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