MAUDE Adverse Event Report: PHASE SCIENTIFIC INTERNATIONAL LIMITED INDICAID COVID-19 RAPID ANTIGEN AT-HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 22X0085

Device Problems False Positive Result (1227); Use of Device Problem (1670); Material Integrity Problem (2978)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

Phase scientific rapid antigen covid-19 tests from lot: 22x0085 will report a (false) positive result if the buffer solution is properly applied to the test device without a nasal swab being performed.All tests are positive regardless of covid status.Also note that the nasal swabs are very flimsy and difficult to use properly.

• Brand Name: INDICAID COVID-19 RAPID ANTIGEN AT-HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): PHASE SCIENTIFIC INTERNATIONAL LIMITED
• MDR Report Key: 17143194
• MDR Text Key: 317455330
• Report Number: MW5118419
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/13/2023

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: Lay User/Patient
• Device Expiration Date: 05/15/2023
• Device Lot Number: 22X0085
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2023
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White