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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUMASIS CO., LTD. CELLTRION DIATRUST COVID-19 AG HOME TEST; IN VITRO DIAGNOSTICS
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HUMASIS CO., LTD. CELLTRION DIATRUST COVID-19 AG HOME TEST; IN VITRO DIAGNOSTICS Back to Search Results
Device Problems Unable to Obtain Readings (1516); Computer System Security Problem (2899)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
On (b)(6) 2022, a user left a review comment on the ubuy website stating that this test is not valid, a rip off and complained this makes customer to pay for providing their information via app.Importer comments: this complaint is quite uncertain to determine of the complaint but based on user's review comments, it is suspected "invalidity" of app which might the application for activation is not valid.Due to the system functionality to not allow seller can leave the comments on the website, it is not able for us to follow up to collect additional information, such as product information (lot #, expiration date etc.) and any further information to investigate the type of complaint following by reporter's consent.
 
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Brand Name
CELLTRION DIATRUST 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 Key13828091
MDR Text Key295143699
Report Number3008719759-2022-00054
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/18/2022
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
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/20/2022
Event Location Home
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/19/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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