MAUDE Adverse Event Report: SIEMENS HEALTHINEERS /HEALGEN SCIENTIFIC LLC. CLINITEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem False Positive Result (1227)

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

Event Date 12/17/2022

Event Type  malfunction  

Event Description

This report is about at home covid antigen tests by clinitest and distributed by siemens healthineers, lot 2202052eua, ref (b)(4).The tests were in a box of five with the bar code (b)(4).I got the box free (thank you!) from usps/fed gov in early 2022.The directions say swirl qtip in nasal passages then dunk the qtip in tube of liquid for 1 min.Before throwing out the qtip, smush out all the liquid from the cottony end.Then put cap on tube, turn tube upside down, and squeeze exactly 4 drops into the test hole.The directions say if you squeeze more than 4 drops then the test could give false positive results.It's easy to deposit the drops when the liquid is relatively swishy and clear.But this report is about when there's snot.So if there's gunk in your sinuses (likely with covid) it absorbs much of the liquid and clogs up the dropper.This means you have to squeeze a bit to get anything out.But squeezing the tube makes the top pop off, liquid spills everywhere.Now more than 4 drops have been deposited.I had a mild case and have been symptom-free for two days but keep testing positive.Is that bc i'm truly infectious - or because the contents of the tube keep spilling onto the test? i don't have health insurance to get more tests.Guess i'll never know.(b)(6) the siemens covid test is incompatible with covid snot.In all three tests the entire contents of the tube spilled out after the top popped off.The directions say any amount other than 4 drops isn't accurate.

• Brand Name: CLINITEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS /HEALGEN SCIENTIFIC LLC.
• MDR Report Key: 16025547
• MDR Text Key: 306076431
• Report Number: MW5113882
• 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: 12/17/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White