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U.S. Department of Health and Human Services

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

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HUMASIS CO., LTD. DIATRUSTTM COVID-19 AG HOME TEST IN VITRO DIAGNOSTICS Back to Search Results
Device Problem False Negative Result (1225)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
On august 8, an amazon customer commented that the product was false negative: customer's friend who the customer was in contact with for several days came down with covid. This customer got symptom and took 2 of these tests. Both came out negative. The reporter took 2 of a different home test about 10 days later and both came back very positive. Importer comments: due to the system functionality to not allow seller can leave the comments on the website or contact the reporter, it is not able for us to follow up to collect additional information, such as product information (lot #, expiration date, etc. ) and any evidence of pcr result to prove false result etc following by reporter's consent.
 
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Brand NameDIATRUSTTM COVID-19 AG HOME TEST
Type of DeviceIN VITRO DIAGNOSTICS
Manufacturer (Section D)
HUMASIS CO., LTD.
88, jeonpa-ro
dongan-gu
anyang-si, gyeonggi-do 14042
KS 14042
MDR Report Key15307823
MDR Text Key298776560
Report Number3008719759-2022-00108
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 Non-Healthcare Professional
Type of Report Initial
Report Date 08/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/08/2022
Event Location Home
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

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