MAUDE Adverse Event Report: COVID TEST; REAGENT, CORONAVIRUS SEROLOGICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

(b)(6) from (b)(6) has tested negative for the rapid covid test and for the routine test.He cannot taste or smell and is getting worse.He has many symptoms of covid.I feel he has a variant that was not detected by the test.Fda safety report id # (b)(4).

• Brand Name: COVID TEST
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 11207274
• MDR Text Key: 228210486
• Report Number: MW5098891
• Device Sequence Number: 1
• Product Code: QKO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• 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 Number: 1
• Patient Outcome(s): Hospitalization; Other