MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINITEST RAPID COVID-19 ANTIGEN SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number GCCOV-502A-H4US (11561910)

Device Problems Device Difficult to Setup or Prepare (1487); Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper Flow or Infusion (2954)

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

Event Date 01/18/2023

Event Type  malfunction  

Event Description

I was using government-provided (via mail) covid 19 test at home.Extraction tube tip was extremely slow releasing buffer mixed with sample.Upon application of more pressure to increase release rate from the tip, the tip came off the extraction tube with force, sending the buffer-sample mix spraying out in all directions.Box contained 4 test kits and 2/4 had this issue.Clinitest rapid covid-19 antigen self test siemens healthineers lot 2203186eua, expiration 2023- 01, ref (b)(4) bar code (b)(4) unlabelled code on side flap of box (b)(4).

• Brand Name: CLINITEST RAPID COVID-19 ANTIGEN SELF TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.
• MDR Report Key: 16214630
• MDR Text Key: 307889665
• Report Number: MW5114391
• Device Sequence Number: 2
• 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: 01/18/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/31/2023
• Device Model Number: GCCOV-502A-H4US (11561910)
• Device Lot Number: 2203186EAU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2023
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Ethnicity: Hispanic
• Patient Race: White