MAUDE Adverse Event Report: HEALGEN SCIENTIFIC LLC CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST; COVID RAPID ANTIGEN SELF-TEST

Catalog Number 11561910

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2022

Event Type  malfunction  

Event Description

As holders of the emergency use authorization, siemens healthcare diagnostics is submitting this report on behalf of the manufacturer healgen scientific.The customer reported false negative result for covid on clinitest covid19 self test when compared with result from a pcr test done at doctor's office.There was no reported injury due to this event.

Manufacturer Narrative

More information was requested from the customer to perform further investigation, however customer declined to provide futher information limiting investigation.Customer performed one covid rapid antigen self-test each day for 3 days.Result of all 3 tests were negative.After 3rd test, on the same day customer visited doctor's clinic where a pcr test was performed.Result of pcr test was positive.The cause of this event is unknown.

Manufacturer Narrative

The manufacturer, healgen, has completed the investigation.The manufacturing records for the lot in question were reviewed, and no irregularities were found.Retained samples of the lot in this complaint were tested and the customer complaint could not be reproduced.The cause of this event is unknown.

• Brand Name: CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST
• Type of Device: COVID RAPID ANTIGEN SELF-TEST
• Manufacturer (Section D): HEALGEN SCIENTIFIC LLC; 3818 fuqua st; houston TX 77047
• Manufacturer (Section G): ZHEJIANG ORIENT GENE BIOTECH CO. LTD.; #3784 east yangguang avenue; dipu street anji; huzhou, zhejiang 31330 0; CH 313300
• Manufacturer Contact: cindy horton ; 3818 fuqua st; houston, TX 77047
• MDR Report Key: 15756548
• MDR Text Key: 307293761
• Report Number: 3009238284-2022-00014
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11561910
• Device Lot Number: 220258EUA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1