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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVID 19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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COVID 19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anxiety (2328); Depression (2361)
Event Description
Test results not available after several days. My child has been isolated in her room possibly unnecessarily because the results aren't in yet. She has anxiety and depression and this is making it worse. There's no way to report the issue to the company. Waited in the car in line for 7. 5 hours with no food to get tested. Test results are past due and cannot reach anyone on the phone. When selecting option for results it's hangs up on you. After waiting on hold for an hour to schedule, they hang up on you. My child has been isolated in her room possibly unnecessarily because the results aren't in yet. This is unacceptable.
 
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Brand NameCOVID 19 TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
MDR Report Key13168221
MDR Text Key283336456
Report NumberMW5106444
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 01/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 01/04/2022 Patient Sequence Number: 1
Treatment
AYEGESTIN ; CALCIUM; LUPRON; PROAIR INHALER ; ZINC
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