MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COVID-19 AT-HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number	09666672160
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 can act as a link between the capture and detector antibodies, leading to non-specific binding and false positive results.Other potential causes of sample deviation and poor reproducibility include: test interferences from patient-specific factors, such as the presence of human antibodies (for example, rheumatoid factor, human anti-mouse antibodies (also known as hama), or other non-specific antibodies) or highly viscous specimens could lead to false positive results.Samples containing human common cold coronavirus, influenza virus, rhinovirus, metapneumovirus, and adenovirus may have a possibility of providing false-positive results.Insufficient cleaning of the workspace, insufficient disinfection of the instrument, or inappropriate use of protective equipment (for example, failing to change gloves between patients) could increase the risk of cross-contamination between specimens with subsequent false-positive results.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 did not identify a product problem.
Event or Problem Description
There was an allegation of a false positive result with the covid-19 at-home test.It was reported that the patient received a positive test result with the covid-19 at-home test.The patient was retested 45 minutes later with the covid-19 at-home test and the result was negative.The patient was retested 2 hours later with the covid-19 at-home test and the result was negative.The patient was retested 3 hours later with the covid-19 at-home test and the result was negative.The patient had a covid test performed at her doctor's office on (b)(6) 2025 and the result was negative.The type or brand of test that was used was not provided.A pcr (polymerase chain reaction) test was not performed.The patient was not symptomatic.No other information can be provided.No additional information about treatment and outcome was provided.

• Brand Name: COVID-19 AT-HOME TEST
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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; indianapolis, IN 46250
• MDR Report Key: 21708791
• Report Number: 1823260-2025-00913
• Device Sequence Number: 15478613
• Product Code: QKP
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EUA210661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/14/2025
• Device Catalogue Number: 09666672160
• Device Lot Number: 53K5161T1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female