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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. COVID-19 ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. COVID-19 ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Catalog Number 195-160
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2023
Event Type  malfunction  
Event Description
Received two boxes of covid test at home kits.Neither box had solution.Necessary to perform test.Would like another two boxes that have complete parts in them.Covid-19 antigen self test did not have dropper in neither of two kits.Each kit containing 2 tests.
 
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Brand Name
COVID-19 ANTIGEN TEST
Type of Device
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
MDR Report Key16195022
MDR Text Key307679585
Report NumberMW5114350
Device Sequence Number2
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 01/16/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date06/25/2023
Device Catalogue Number195-160
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/17/2023
Patient Sequence Number1
Patient Age81 YR
Patient SexFemale
Patient Weight63 KG
Patient EthnicityHispanic
Patient RaceWhite
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