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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERKINELMER, INC. PERKINELMER COVID-19 ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
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PERKINELMER, INC. PERKINELMER COVID-19 ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Distress (2329)
Event Date 02/01/2021
Event Type  malfunction  
Event Description
Mental distress; i had a positive covid test come back on (b)(6) 2021 and 2 days later had another test come back negative on (b)(6) 2021.I feel like the test is faulty at (b)(6) hospital where i received my first test.Second test was done at (b)(6) urgent clinic.I was never sick and i had been around my grandmother's helping them and they tested negative.I live alone and rarely go out.I double mask and i'm very careful.This false result had my 5 mental illnesses go crazy for the first 2 days feeling afraid of myself.I thought i was making myself sick.I never felt sick nor was i.I don't trust (b)(6) hospitals tests anymore.(b)(6) urgent care is more reliable.I was told by (b)(6) communicable diseases investigator that they can't do anything about it.I had to have been sick and on my last 2 days of my sickness.I test often and they are wrong for putting me in this category when i never had the sickness.It was there false testing.Fda safety report id# (b)(4).
 
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Brand Name
PERKINELMER COVID-19 ANTIGEN TEST
Type of Device
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
PERKINELMER, INC.
940 winter street
waltham MA 02451
MDR Report Key11371975
MDR Text Key233476735
Report NumberMW5099556
Device Sequence Number1
Product Code QKP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age38 YR
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