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

Catalog Number 11562089

Device Problem Missing Information (4053)

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

Event Date 10/10/2022

Event Type  malfunction  

Manufacturer Narrative

1 test cassette in the kit did not have the control and test line markings, required to read the output result.In absence of the labels, customer used another test cassette from the kit testing.The cause of the 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.The customer reported that printed text for c and t lines, were missing on cassette of one of the tests in the kit.There was no reported injury due to this event.

Manufacturer Narrative

The manufacturer healgen has completed the investigation.Retained samples from lot 2203332 were checked and all cassettes were found in a good condition.The manufacturing process was also reviewed.The appropriate steps were found to be followed per the 2-step standard operating procedure (sop).Based on the investigation, if either of the "t" or "c" markings are missing on a cassette, that cassette should be picked out during step 2 of the cassette assembly process.The defective product should have been picked out during the assembly process.Per the supplier, a lack of ink during production could have caused missing "t" and "c" markings on the cassette and missing markings in a test kit is most likely due to operator error.Training will be enhanced for relative operators and the importance of strictly complying with the sop during the production process will be enforced.Physical defects will continue to be monitored by the supplier.The issue was not reproduced and is not considered to be systemic.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: 15775774
• MDR Text Key: 307512945
• Report Number: 3009238284-2022-00015
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 11562089
• Device Lot Number: 2203332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• 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