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 09/12/2022

Event Type  malfunction  

Event Description

The consumer reported discrepant results with the covid-19 at-home test.On (b)(6) 2022 the consumer began experiencing symptoms.The specific symptoms were not provided.On (b)(6) 2022 at 6:20 pm the consumer performed a covid-19 at-home test and the result was negative on (b)(6) 2022 at 6:30 pm the consumer performed a covid-19 at-home test and the result was positive.No pcr test was performed.No other information can be provided.No additional information about treatment and outcome was provided.

Manufacturer Narrative

Occupation is patient/consumer for the test performed on (b)(6) 2022 at 6:20 pm, the consumer had difficulty determining what 3/4 inches of the swab into his nostril was.Product labeling states: "holding the stick end of the swab, gently insert the foam end of the swab into the nostril approximately ¾ of an inch." 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.There is a low probability of false positives occurring.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.The test does not differentiate between sars-cov and sars-cov-2.Refer to the limitations section of the instructions for use.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).

• 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: 15589547
• MDR Text Key: 307025183
• Report Number: 1823260-2022-03135
• 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

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/07/2022
• Device Catalogue Number: 09666672160
• Device Lot Number: 53K32A2T11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2022
• 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: LEVETIRACETAM
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 84 KG