MAUDE Adverse Event Report: SIEMENS / HEALGEN SCIENTIFIC LLC. CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST MULTIPACK (5 TESTS) (LOT 2202069EUA); CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number GCCOV-502A-H5US (11556712)

Device Problem Device Ingredient or Reagent Problem (2910)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

I have an unexpired siemens/healgen scientific clinitest rapid covid-19 antigen self-test multipack (5 tests) where there is none or not enough liquid in any of the sealed tubes and therefore cannot use them.(lot 2202069eua).Printed expiration date is 2022-12, but it was extended to 2024-01 on the fda eua website (https://www.Fda.Gov/media/162503/download).Reference reports: mw5118210, mw5118211, mw5118212, mw5118213.

• Brand Name: CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST MULTIPACK (5 TESTS) (LOT 2202069EUA)
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): SIEMENS / HEALGEN SCIENTIFIC LLC.
• MDR Report Key: 17078479
• MDR Text Key: 316713886
• Report Number: MW5118209
• 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: 06/03/2023

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: 01/31/2024
• Device Catalogue Number: GCCOV-502A-H5US (11556712)
• Device Lot Number: 2202069EUA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2023
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White