MAUDE Adverse Event Report: CORONACHECK COVID-19 IGG/IGM RAPID TEST CASSETTE; REAGENT, CORONAVIRUS SEROLOGICAL

Device Problem False Negative Result (1225)

Patient Problem Viral Infection (2248)

Event Date 12/21/2021

Event Type  malfunction  

Event Description

Coronacheck covid-19 igg/igm rapid test cassette use for covid-19 under emergency use authorization (eua): monday (b)(6) 2021 pm: we receive an email from my daughter's school that she had an exposure on friday (b)(6) 2021, tuesday (b)(6) 2021 am: she gets a pcr test.We decide to seek out a rapid test since we are in a house with at-risk individuals.Tuesday (b)(6) pm: we are spending the holidays in a remote town with extended family - we were unable to locate any rapid tests other than one local pharmacy just started administering the igg/igm rapid test.I bring my daughter to the pharmacy for the test.The reading was that she had some immunity (igg; she had received 2 doses pfizer in the late spring 2021) and no igm.She had also demonstrated flu-like symptoms for 24+ hrs prior to the test.Weds (b)(6) 2021 am: she received positive pcr result.As a pharmacist myself, my assessment is that she possibly received a false negative since she was within a week of exposure and the antibody test may be accurate only 1-3 weeks after exposure/infection.My concern however, is that she had active symptoms and the pcr test earlier in the day was positive.Anyone that uses this test should be advised to also take a different test to corroborate results.Fda safety report id# (b)(4).

• Brand Name: CORONACHECK COVID-19 IGG/IGM RAPID TEST CASSETTE
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 13093225
• MDR Text Key: 282902847
• Report Number: MW5106284
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White