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

Catalog Number 09666672160

Device Problems False Positive Result (1227); Material Integrity Problem (2978)

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

Event Date 02/09/2023

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.A false negative may occur when sampling is not performed as described in the instructions for use (ifu).The limit of detection varies depending on the type of test.A negative result may occur due to an insufficient amount of virus in the sample.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).

Event Description

The consumer reported a false positive result with the covid-19 at-home test compared to a negative result with the covid-19 at-home test.On (b)(6) 2023, the consumer performed two covid-19 at-home test and the results were positive in one test and negative in the other test from the same package.The customer is healthy and had no symptoms.No treatment was been prescribed.

• 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: 16584524
• MDR Text Key: 312235488
• Report Number: 1823260-2023-00915
• 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: 03/21/2023

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 Catalogue Number: 09666672160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/21/2023
• 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
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 62 KG