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

Catalog Number 11556712

Device Problem False Negative Result (1225)

Patient Problem Fever (1858)

Event Date 08/09/2022

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.There was no reported injury due to this event.

Manufacturer Narrative

Udi could not be included in this report since customer did not provide lot number.Event notified to healgen on (b)(6) 2022 was informed to siemens on (b)(6) 2022.Customer was vaccinated but had symptoms.The manufacturer requested more information from the customer to perform further investigation, however no response was received from the customer even after multiple attempts.The cause of this event is unknown.

Manufacturer Narrative

Siemens showed due diligence in attempting to obtain more information from the customer however, the customer has not responded.Without the lot information, further investigation is not possible.The cause of this event is unknown.

• Brand Name: CLINITEST RAPID COVID-19 ANTIGEN 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: 15315440
• MDR Text Key: 305371506
• Report Number: 3009238284-2022-00009
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11556712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 09/13/2022
• 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