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

Catalog Number 11561910

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cellulitis (1768)

Event Date 12/30/2022

Event Type  Injury  

Manufacturer Narrative

Udi could not be included in this report since customer did not provide covid test kit information.Siemens has requested more information from the customer to be able to perform further investigation.Both patients had used both nostrils for testing, and received negative results for covid which was confirmed during testing upon hospital admission.Both patients had multiple symptoms - headaches, rash, swelling.Per communication from customer, both received similar treatments.Hospital performed various tests to diagnose and confirm cellulitis.Per customer, patient 1 was admitted to hospital once only, however, patent 2 was hospitalized a second time for complications of cellulitis moving to her other eye with suspected infectious meningitis.The cause of this event is unknown.

Event Description

As holders of the emergency use authorization, siemens healthcare diagnostics is submitting this report on behalf of the manufacturer healgen scientific.Customer alleges siemens clinitest covid-19 antigen test is the cause of cellulitis to two children in her care.Per customer email, both patients used separate nasal swabs from the same test kit from lot2203174eua and endured same reaction within days leading to hospitalization.

Manufacturer Narrative

The manufacturer healgen has completed the investigation.Retained samples from lot 2203174eua were inspected, and no abnormalities were found.Batch records for lot 2203174eua were reviewed, and no abnormalities or associated deviations were found.Per the supplier investigation:- - swabs are packaged in plastic-paper bags in a clean room; they are then sent out for ethylene oxide (eo) sterilization.Following sterilization, the swabs undergo quality control testing, which includes several tests such as: appearance, physical dimension, material, swab head binding test, sterilization, eo residual test, and package.After the successful completion of the quality control checks, the swabs are released for shipment.- the swabs are sterilized using ethylene oxide (eo) sterilization process and tested according to iso 11737-2:2016 sterile test standard regulations.Additional documents included are sterilization statement (attachment 1) and biocompatibility statement (attachment 2).- three swab sterilization lots (20220226, 20220228, and 20220302) were used in the complaint lot 2203174eua.All three related sterilization lots passed sterilization testing and met all required quality control criteria.- a review of the materials used during manufacturing was conducted.No chemicals outside the substances in the bill of materials (bom) were used or came in contact with the product.- semi-finished products from the production line were inspected, and no abnormalities were identified.The product warehouse was also checked; no abnormalities were found.- the associated batch records were reviewed (by supplier), and no abnormalities or deviations were found.- the retained samples were reviewed, and also no abnormalities were found.Lastly, retained samples from the three swab sterilization lots (20220226, 20220228, and 20220302) were sent out for sterility testing.The results showed that the test articles had no detectable viable microorganisms under the test condition.For the reasons listed above, an issue with the swab or kit lot could not be confirmed.The cause of this event is unknown.

• Brand Name: CLINITEST RAPID COVID-19 ANTIGEN TEST
• Type of Device: CLINITEST 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: 16294635
• MDR Text Key: 308757138
• Report Number: 3009238284-2023-00004
• 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: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11561910
• Device Lot Number: 2203174EUA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/06/2023
• 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
• Patient Outcome(s): Hospitalization
• Patient Sex: Female