MAUDE Adverse Event Report: LABORATORIES, INC. SARS-COV-2 ANTIGEN RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number L031-118M5

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Event Date 05/29/2023

Event Type  malfunction  

Event Description

This pertains to a flowflex sars-cov-2 antigen rapid test.This test is manufactured by acon biotech and identified as lot cov1095004, ref l031-118m5, dated (b)(6) 2023 and with another identifier (b)(6).This test kit was distributed through (b)(6).Upon using the test this evening, there were no written instructions in english but only in foreign languages that i cannot read.Having specific instructions is important since some tests require three drops and some require four drops.Timing on tests can also vary among manufacturers.

• Brand Name: SARS-COV-2 ANTIGEN RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): LABORATORIES, INC.
• MDR Report Key: 17052418
• MDR Text Key: 316503023
• Report Number: MW5118086
• 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: Unknown
• Type of Report: Initial
• Report Date: 05/29/2023

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 Expiration Date: 03/09/2023
• Device Catalogue Number: L031-118M5
• Device Lot Number: COV1095004
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2023
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic