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

Catalog Number 09666672160

Device Problems False Negative Result (1225); No Device Output (1435)

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

Event Date 06/25/2022

Event Type  malfunction  

Manufacturer Narrative

The case was sent to the manufacturer for investigation.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 relative diagnostic sensitivity compared to rt-pcr, written in the instructions for use of pilot®covid-19 at-home test is 93.2%.Probable causes of false negative result: inappropriate sampling: it might be a false negative when sampling is not performed as described in the ifu.The insufficient amount of viruses in samples: the limit of detection varies with the type of test.A molecular test, such as a pcr test has a higher sensitivity than a rapid antigen test.As a result, it could be a false negative with rapid tests at the beginning of symptoms or with a small amount of covid-19 virus, lower than the detection limit of the product.The investigation did not identify a product problem.

Event Description

We received an allegation about discrepant results for 1 patient's sample tested with covid-19 at-home test and obtained negative and positive results from the same kit.The time difference between the tests is unknown.

• Brand Name: COVID-19 AT-HOME TEST
• Type of Device: 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: 17980013
• MDR Text Key: 326404572
• Report Number: 1823260-2023-03387
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EUA210661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/07/2023
• Device Catalogue Number: 09666672160
• Device Lot Number: 53K33D2T1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1