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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SD BIOSENSOR COVID 19 AT HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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SD BIOSENSOR COVID 19 AT HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Catalog Number 99COV200LEN02
Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Insufficient Information (4580)
Event Date 07/23/2022
Event Type  malfunction  
Event Description
Went to test with covid test kit i received from fda but could not put drops of sample into tester because the kit did not come with a drop nozzle. "roche". Fda safety report id# (b)(4).
 
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Brand NameCOVID 19 AT HOME TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
SD BIOSENSOR
MDR Report Key15103860
MDR Text Key296669040
Report NumberMW5111095
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 Patient
Type of Report Initial
Report Date 07/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number99COV200LEN02
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

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