MAUDE Adverse Event Report: SD BIOSENSOR, INC. PILOT COVID-19 AT-HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number 99COV200L-EN02

Device Problems False Negative Result (1225); Nonstandard Device (1420); Contamination /Decontamination Problem (2895)

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

On four consecutive days i used sd biosensor pilot covid-19 at-home tests with lot #53k38p2t1 that were later recalled by the fda due to bacterial contamination.I did not have any signs of bacterial infection, but i suspect false negative results, which is listed as a concern in the recall information.I used the tests because i had covid symptoms starting 3 to 4 days after a confirmed exposure.I continued to have symptoms for 3 to 4 weeks.After a week of illness i called my health care provider (b)(6), and a nurse there advised that i did not need to come in for a pcr test, partly because of the negative home test results which are now in question.Reference reports mw5117581, mw5117582, mw5117584.

• Brand Name: PILOT COVID-19 AT-HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): SD BIOSENSOR, INC.
• MDR Report Key: 16946747
• MDR Text Key: 315417155
• Report Number: MW5117583
• 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: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/16/2023
• Device Catalogue Number: 99COV200L-EN02
• Device Lot Number: 53K38P2T1
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN 10MG 1X DAY ; CBD OIL, 20MG 1X MORNING, 2X BEDTIME ; CETIRIZINE 10MG 1 OR 2X DAY ; FLAXSEED OIL 1200MG 2X DAY ; GABAPENTIN 600MG 2X DAY ; GARLIC 2000MG 2X DAY ; LORAZEPAM 0.5MG, USED RARELY FOR SLEEP ISSUES; VITAMIN D3 1000IU 1X DAY DURING THE DARKER MONTHS OF THE YEAR
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White