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

Catalog Number ZZ0047CE

Device Problems Component Missing (2306); Expiration Date Error (2528)

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

Event Date 01/03/2023

Event Type  malfunction  

Event Description

The vials of buffer were empty.Also the lot number on the vial was wz04062022a and the lot number on the carton was 22s0192.Also the expiry on the carton has a typo: 2023-05-18 while the vial expiry date is 2023-08-05, making it confusing what the expiry date is, may or august?.

• 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: 16103137
• MDR Text Key: 306795049
• Report Number: MW5114163
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/03/2023

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: 08/05/2023
• Device Catalogue Number: ZZ0047CE
• Device Lot Number: 22S0192 WZ04062022A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2023
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White