MAUDE Adverse Event Report: SARS COV2 REAGENT; REAGENT, CORONAVIRUS SEROLOGICAL

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Date 06/26/2020

Event Type  No Answer Provided  

Event Description

False positive sars cov2 result, resident asymptomatic on (b)(6); swab on (b)(6) - positive at facility (b)(6) negative at hospital, resulted in unnecessary hospitalization.Fda safety report id# (b)(4).

• Brand Name: SARS COV2 REAGENT
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 10319557
• MDR Text Key: 200439095
• Report Number: MW5095682
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR