MAUDE Adverse Event Report: BINX HEALTH LTD. COVID PCR TEST; COVID-19 TEST HOME COLLECTION KIT DEVICES

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  malfunction  

Event Description

Received a false positive result from a binx health covid test.I had tested negative 3 days prior to the positive result.Upon receiving the positive result, i had 3 additional pcr tests that all reported negative results.Fda safety report id# (b)(4).

• Brand Name: COVID PCR TEST
• Type of Device: COVID-19 TEST HOME COLLECTION KIT DEVICES
• Manufacturer (Section D): BINX HEALTH LTD.
• MDR Report Key: 11768921
• MDR Text Key: 249021424
• Report Number: MW5101133
• Device Sequence Number: 1
• Product Code: QLW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/30/2021

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: 05/03/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR