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

Catalog Number 09666672160

Device Problem False Negative Result (1225)

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

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer.The case was sent to the manufacturer for investigation.Potential causes of sample deviation and poor reproducibility can be due to mucous membranes present in the nose, mucin and iga act as a bridge between capture and detector, which may cause non-specificity.In general, the rapid ag test result should not be the sole basis for the diagnosis; depending on the situation confirmatory testing is required (pcr).The investigation could not identify a product problem.

Event Description

The consumer reported a false negative result with the covid-19 at-home test compared to a second positive result with the covid-19 at-home test.On (b)(6) 2022, at 6:00 p.M., the consumer performed a covid-19 at-home test and the result was negative.On (b)(6) 2022, at 6:00 p.M., the consumer performed a covid-19 at-home test and the result was positive.On (b)(6) 2022, in the morning, the consumer performed two covid-19 at-home tests and the results were both negative.On the same day, the customer had a pcr and the result was not provided.The customer's symptoms started on (b)(6) 2022.The patient has current no symptoms.No other information can be provided.

• Brand Name: COVID-19 AT-HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): SD BIOSENSOR, INC.; c-4th&5th,16, deogyeong-daero; 1556beon-gil, yeongtong-gu; suwon-si, gyeonggi-do 16690 ; KS 16690
• Manufacturer (Section G): SD BIOSENSOR, INC.; c-4th&5th,16, deogyeong-daero; 1556beon-gil, yeongtong-gu; suwon-si, gyeonggi-do 16690 ; KS 16690
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15789220
• MDR Text Key: 303925059
• Report Number: 1823260-2022-03596
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/21/2022
• Device Catalogue Number: 09666672160
• Device Lot Number: 53K32R2T11
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; GLIMEPIRIDE
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 70 KG