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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 Problem Computer System Security Problem (2899)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
User was not able to use the application for the product and commented on the (b)(6) website that the app is not compatible with the phone and he/ she lost one test because the phone could not capture the qr code in time.Importer comments: this was a phenomenon that occurs because the serial number of the product and the application for activation are not synchronized.There is no error with the diagnosis of covid-19 but activation of the application through qr code is part of the product's functionality so that we assessed this is in criteria of "malfunction" according to the 21cfr803.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 ect) 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 Key13549674
MDR Text Key286767501
Report Number3008719759-2022-00044
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 02/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
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 Date01/08/2022
Event Location Home
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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