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

Lot Number 53K38P2T1

Device Problems False Positive Result (1227); Nonstandard Device (1420)

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

Event Date 04/01/2023

Event Type  malfunction  

Event Description

Reporter calling, stating that she received a false-positive result using the pilot at-home covid test.She states that after realizing her result was false-positive, she also learned that the pilot at-home test was recalled and that she has a lot number that is part of this recall.Reporter states she purchased the pilot test from a cvs store on (b)(6) 2023 and was testing out of precaution prior to visiting family members.She obtained a "faint line positive" result on (b)(6) 2023, and was surprised because she had no symptoms.She immediately contacted urgent care to obtain a pcr test and took an additional flowflex antigen test, and both of these returned negative results.Reporter states she contacted cvs regarding the fact that they were selling a product to the public that is under recall, but they refused to let her return the product or refund her money.Reporter also states she contacted pilot regarding her false-positive result but that they were similarly unhelpful to her.Reporter states "they tried to make me feel like i did something wrong." reporter is upset because the product is recalled and she has suffered financial loss as a result.She states the lot number on the box is 53k38p2t1, and that the lot number of the buffer solution is 53h38h3z8.

• Brand Name: PILOT AT-HOME COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): SD BIOSENSOR, INC.
• MDR Report Key: 16895011
• MDR Text Key: 314984050
• Report Number: MW5117381
• 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: 05/08/2023

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 Lot Number: 53K38P2T1
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2023
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female