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

Catalog Number 09666672160

Device Problems False Negative Result (1225); False Positive Result (1227)

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

Event Date 09/21/2022

Event Type  malfunction  

Manufacturer Narrative

Occupation is patient/consumer.The case has been sent to the manufacturer for investigation.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).

Event Description

The consumer reported discrepant results with the covid-19 at-home test.On (b)(6) 2022 the consumer felt aches and body pains and had a headache.On (b)(6) 2022 at 6:00 am the consumer performed a covid-19 at-home test and the result was positive.On (b)(6) 2022 at 9:00 am the consumer performed a covid-19 at-home test and the result was negative.No pcr test was performed.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: 15625583
• MDR Text Key: 307160128
• Report Number: 1823260-2022-03229
• 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: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/21/2022
• Device Catalogue Number: 09666672160
• Device Lot Number: 53K33W1T11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2022
• 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: AMLODIPINE.; ATORVASTATIN.; LEVOTHYROXINE.; OZEMPIC 0.5MG INJECTION SHOT.; PROTONICS.; TRAZODONE.; XANAX 1MG AT BEDTIME.
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 75 KG