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U.S. Department of Health and Human Services

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

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ELLUME LIMITED ELLUME COVID-19 HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. Back to Search Results
Lot Number 21193-441
Device Problem False Positive Result (1227)
Patient Problem Insufficient Information (4580)
Event Date 12/28/2021
Event Type  malfunction  
Event Description
Ellume home test kit was used and the result was positive for covid. Patient tested again with another ellume test kit. Second kit tested positive as well. Patient was then binax now antigen tested and rapid pcr tested; both were negative for covid. Fda safety report id# (b)(4).
 
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Brand NameELLUME COVID-19 HOME TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
Manufacturer (Section D)
ELLUME LIMITED
east brisbane
AS
MDR Report Key13141596
MDR Text Key283153993
Report NumberMW5106393
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2022
Device Lot Number21193-441
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/30/2021 Patient Sequence Number: 1
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