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 09/13/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer for the result obtained on (b)(6) 2022 at 5:20 pm, the consumer squeezed more than 4 drops onto the test device.Product labeling states: "drop 4 drops onto the sample well." the case has been sent to the manufacturer for investigation.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 negative result with the covid-19 at-home test.On (b)(6) 2022 the consumer stated experiencing symptoms that included tiredness, headache, and coughing.On (b)(6) 2022 at 5:20 pm the consumer performed a covid-19 at-home test and the result was negative.On (b)(6) 2022 at 5:20 pm the consumer performed a covid-19 at-home test and the result was positive.On (b)(6) 2022 at 5:50 pm the consumer performed a covid-19 at-home test and the result was positive.No pcr test was taken.No other information can be provided.No additional information about treatment and outcome was 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: 15589511
• MDR Text Key: 307070920
• Report Number: 1823260-2022-03134
• 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: 10/12/2022

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 Expiration Date: 08/21/2022
• Device Catalogue Number: 09666672160
• Device Lot Number: 53K32R1T11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/12/2022
• 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: CRESTOR; LOSARTAN; METFORMIN; ROSUVASTATIN
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 83 KG