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

Catalog Number 11556712

Device Problem Obstruction of Flow (2423)

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

Event Date 12/17/2022

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 that upon squeezing the sample tube to apply sample to clinitest covid test strip, filter pops off the tube due to cloged filter, spewing out sample with reagent.Due to more sample applied than required, the results may be incorrect.Of the 3 tests customer tried, filter of all popped off spilling sample onto test cassettee.There was no reported injury due to this event.

Manufacturer Narrative

Event came to the knowledge of siemens healthineers from healgen who learnt through fda medwatch program email.Customer did not contact siemens or the manufacturer - healgen.The customer failed to follow the instructions provided with the device.Quick reference instructions also mentions to make sure there is a tight fit of filter tip to the tube.This would have avoided filter tip to pop out.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 cause of this event is unknown.

Manufacturer Narrative

The manufacturer healgen has completed the investigation.After reviewing the relevant manufacturing documentation associated with lot number 2202052eua, no irregularities were found by the supplier of tubes.Tests retained from lot number 2202052eua were tested - with buffer solution only, with nasal extract- and with nasal mucus.All devices performed as expected when tested.Based on investigations, manufacturer was unable to replicate the customer's complaint.No irregularities or deviations were observed in the manufacturing documentation for the complaint related lot.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: 16099084
• MDR Text Key: 308401505
• Report Number: 3009238284-2023-00001
• 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: 01/25/2023

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 Catalogue Number: 11556712
• Device Lot Number: 2202052EUA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/25/2023
• 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