MAUDE Adverse Event Report: RAPID SARS-COV2 TEST; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problem False Positive Result (1227)

Patient Problem Epistaxis (4458)

Event Date 04/21/2021

Event Type  malfunction  

Event Description

False positive from rapid test administered by (b)(6) in teen with blood in nose.Teen had heavy nosebleeds prior to testing and had significant amounts of dried blood in nostril at time of sample collection.Rt-qpcr test was negative for sars-cov2.Name of the company: (b)(6).Fda safety report id # (b)(4).

• Brand Name: RAPID SARS-COV2 TEST
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• MDR Report Key: 11723382
• MDR Text Key: 247487389
• Report Number: MW5100955
• Device Sequence Number: 1
• Product Code: QJR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/22/2021

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 Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 58