MAUDE Adverse Event Report: HUMASIS CO., LTD. DIATRUSTTM COVID-19 AG HOME TEST; IN VITRO DIAGNOSTICS

Device Problems False Positive Result (1227); Incorrect Measurement (1383)

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

Event Date 09/20/2023

Event Type  Injury  

Event Description

On october 11, celltrion usa received an email with fda medwatch (ref: mw5146128) that reported by a user on (b)(6) 2023.The user tested himself/herself and his/her child with celltrion covid tests and there appeared to be a line indicating the test was positive.However, the background stayed pink and the line was white/gray and after consulting a provider they said to consider the test invalid and test again in a few days.So the user had order again new test kits and when they arrived the user took a celltrion covid test and again it had what appeared to be a faint gray line but this time background was white so it wasn't as obvious.Then the user tested his/her family members.They also had the same faint grey line.After the initial anxiety about being positive subsided he/she did a 'control' test with just unadulterated reagent (straight from the tube, no sample/swab & no other substances like water, etc.) and the same line appeared.He/she noted that the false positives are rare but this brand has been recalled for them before.The initial ones were going to expire in october and the second batch are going to expire in january.After dong some amateur observations it seems to him/her like there is some issues with fiber degradation on the test strip making the line show gray like an evap line on a pregnancy test.It is not pink or red, it is clearly colorless, and ti shows even when there isn't a sample & it's just reagent, in the past week he/she also took two binax tests and two flowflex tests and none of them had a faint line of any color.Importer's comments: the reference is the mw5146128 from fda.This report is the reporter's family member of 4 cases contained in this report.

• Brand Name: DIATRUSTTM COVID-19 AG HOME TEST
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): HUMASIS CO., LTD.; 88, jeonpa-ro; dongan-gu; anyang-si, gyeonggi-do 14042 ; KS 14042
• MDR Report Key: 17957930
• MDR Text Key: 325952526
• Report Number: 3008719759-2023-00061
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2023,10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2023
• Distributor Facility Aware Date: 11/10/2023
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention