MAUDE Adverse Event Report: CURATIVE INC COVID 19 SWAB; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Virus (2136)

Event Date 01/07/2021

Event Type  malfunction  

Event Description

The facility i work at has had numerous staff and residents test positive through curative, most are asymptomatic.When swabbed through the uch lab, some are coming back negative.I believe false positives are just as concerning as false negatives as we are not required to swab for 90 days following a positive.Fda safety report id # (b)(4).

• Brand Name: COVID 19 SWAB
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): CURATIVE INC; 1600 adams drive, suite 105; menlo park CA 94025
• MDR Report Key: 11177300
• MDR Text Key: 227496122
• Report Number: MW5098829
• Device Sequence Number: 1
• Product Code: QJR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/12/2021

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other