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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELLUME LIMITED ELLUME COVID-19 HOME TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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ELLUME LIMITED ELLUME COVID-19 HOME TEST KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Catalog Number I-SRS-C-01
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Computer System Security Problem (2899)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Event Description
User reported they hacked the bluetooth connection between the analyzer and the android app and switched a negative result to a positive result, and received a positive result certificate from third party proctoring service.
 
Manufacturer Narrative
Investigation not complete at time of initial report. Follow-up to be submitted upon completion of investigation.
 
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Brand NameELLUME COVID-19 HOME TEST KIT
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ELLUME LIMITED
57 didsbury st
east brisbane, qld 4169
AS 4169
Manufacturer Contact
sapna kamath
57 didsbury st
east brisbane, qld 4169
AS   4169
MDR Report Key13702993
MDR Text Key287133697
Report Number3014862188-2022-00484
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA203011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberI-SRS-C-01
Device Lot Number21109-002
Was Device Available for Evaluation? No
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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