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

Catalog Number GCGOV-502A-H4US (11561910)

Device Problems Product Quality Problem (1506); Defective Device (2588)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/31/2023

Event Type  malfunction  

Event Description

Box of physically defective healgen scientific llc clinitest rapid covid antigen self-test distributed by siemens healthineers.Lot 2204623eua.Ref (b)(4) ; 2 or 3 of the plastic tips that go on the tube turned out to be closed and would not allow the liquid + products of swabbing to drip out.As pressure was increased, the first tube began instead foaming up and out of the junction between the tip and the tube.We tried again with a second tip.It did eventually allow the liquid out, but in a massive sploosh that probably invalidated the result, got all over my hands and onto the one remaining testing bar.Not ideal for our household developing potential covid symptoms.Reference report mw5116233.

• Brand Name: CLINITEST RAPID COVID-19 ANTINGEN SELF-TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): HEALGEN SCIENTIFIC LLC.
• MDR Report Key: 16673285
• MDR Text Key: 312625509
• Report Number: MW5116232
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: GCGOV-502A-H4US (11561910)
• Device Lot Number: 2204623EUA
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White