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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCESS BIO INCORPORATE ON/GO COVID-19 ANTIGEN SELF-TEST

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ACCESS BIO INCORPORATE ON/GO COVID-19 ANTIGEN SELF-TEST Back to Search Results
Model Number N/A
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/09/2022
Event Type  malfunction  
Manufacturer Narrative
We have investigated this incident to better understand facts/circumstances and to identify root causes of this event. See below for the investigations and results. 1. Review of previous customer complaints a. Breakage of swab inside of nostril was a first incident reported out of millions of tests distributed. In the light of numbers of test distributed and used by intended users, this appears to be isolated event which is likely caused by user error. 2. In-house clinical studies a. Hundreds of our tests are being tested by access bio employees every week to monitor covid-19 infection status and such breakage of swabs were never reported. 3. Communication with vendor a. Flexibility of the reported lot of nasal swabs (#89432) was tested and passed the test by a vendor. Such breakage inside of nostril was also first incident reported to the vendor. 4. Communication with the complainant a. The complainant noted via phone call that her child was a bit resistant when she was trying to collect sample from her child. This indicates that there might be extensive forces applied to nasal swabs that might lead to breakage of swabs inside nostril. The nasal swabs is suitable for sample collection in the intended nasal area and for short contact. It is not intended to be used in conditions that require the ability to resist deformation. The said investigations demonstrated that this breakage of nasal swab inside nostril might be caused by a user error. Access bio will continue to monitor future complaints through our data trending programs and take further actions based on identified valid trends.
 
Event Description
On may 9 2022, access bio received a complaint via email regarding the incident that a portion of swab was broken during sample collection inside the nostril of a child and stuck in his nose, requiring the complainant to visit an ent to remove the portion from child's nose. The swab was stuck in his nose for about 5 hours and it irritated the child but the child did not have severe pain or issue in breathing according to his mother. The portion was removed successfully on the same day.
 
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Brand NameON/GO COVID-19 ANTIGEN SELF-TEST
Type of DeviceCOVID-19 ANTIGEN SELF-TEST
Manufacturer (Section D)
ACCESS BIO INCORPORATE
65 clyde rd suite a
somerset NJ 08873
Manufacturer Contact
david park
65 clyde rd suite a
somerset, NJ 08873
7328734040
MDR Report Key14711690
MDR Text Key295904104
Report Number3003966368-2022-00134
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 06/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Model NumberN/A
Device Catalogue NumberRCPM-00279
Device Lot NumberCP21L59
Was Device Available for Evaluation? No
Date Manufacturer Received05/09/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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