MAUDE Adverse Event Report: HEALGEN SCIENTIFIC CLINITEST RAPID COVID-19 ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number 11561910

Device Problem Obstruction of Flow (2423)

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

Event came to the knowledge of siemens healthineers on 04-07-2023 from healgen who learnt through fda medwatch program email on 04-06-2023 with medwatch report#mw5116232.Customer has also filed medwatch report# mw5116233 which is duplicate of mw5116232.Hence, siemens is submitting this response against mw5116232 only.Customer did not contact siemens or the manufacturer - healgen.For any questions or concerns, customer care hotline phone number and email are provided on quick reference instructions provided with each test kit per the safety data sheet, "not classified as dangerous according to directive (ec) no.1272/2008.".Although the buffer solution is not intended to come in contact with the patient or user, however, spewing will not result in any adverse event.The manufacturer healgen has completed the investigation.-retained samples were checked and no irregularities were observed.-extraction tube supplier reported no irregularities associated with the complaint related batches.Inspection frequency of tubes and qc sampling quantity of filters has been increased as a corrective action.-according to our investigation, it is important that the tube is squeezed as instructed in the instructions for use (ifu).The user should gently squeeze the bottom of the tube so that the liquid will drip slowly.Squeezing near the cap of the tube could result in the cap ¿popping¿ off.Quick reference instructions also mentions to make sure there is a tight fit of filter tip to the tube.The cause of this event is unknown.

Event Description

Customer has filed the complaint through medwatch portal - mw5116232.As holders of the emergency use authorization, siemens healthcare diagnostics is submitting this report on behalf of the manufacturer healgen scientific.The customer reported that 3 filter cap tips were closed and would not allow sample flow.Upon squeezing the sample tube with higher pressure to apply sample to clinitest covid test strip, the sample mixture reagent splashed out, including onto the hands.There was no reported injury due to this event.Customer also filed another medwatch - mw5116233.After going through the same, it was found to be duplicate of mw5116232.Hence this mdr will be the response against both medwatch forms and separate response will not be submitted for mw5116233.

• Brand Name: CLINITEST RAPID COVID-19 ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): HEALGEN SCIENTIFIC; 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: 16773467
• MDR Text Key: 313989612
• Report Number: 3009238284-2023-00010
• 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
• Report Date: 04/19/2023

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 Expiration Date: 02/28/2023
• Device Catalogue Number: 11561910
• Device Lot Number: 2204623EUA
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 04/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1