MAUDE Adverse Event Report: BIOHIT HEALTHCARE(HEFEI) CO.LTD SARS-COV-2 N PROTEIN IGM ANTIBODY TEST; REAGENT, CORONAVIRUS SEROLOGICAL

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2022

Event Type  malfunction  

Event Description

I am an international student who just graduated in (b)(6) 2021.I already brought the ticket go back to (b)(6) 2022, but before i got a fake positive result before the flight which made me cannot get in the flight.I got 2 different covid test results in 24 hours in 2 labs.First test was on (b)(6), pcr is negative, the result of sars-cov-2 igg/igm rapid test is igm negative, igg positive.N-protein igm antibody is positive.I heard the result may be a fake, so i decided to another lab do the same test again on (b)(6) morning, which the results is pcr is negative, the result of sars-cov-2 igg/igm rapid test is igm positive, igg positive.N-positive igm antibody is negative.I got the fully shots moderna (b)(6) 2021.This fake test result made me miss the airplane and due to the travel policy of (b)(6) and limited tickets going back to (b)(6) i cannot go back recently, my i20 have expired.All of these are due to this irresponsible test.Fda safety report id # (b)(4).

• Brand Name: SARS-COV-2 N PROTEIN IGM ANTIBODY TEST
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): BIOHIT HEALTHCARE(HEFEI) CO.LTD
• MDR Report Key: 13591769
• MDR Text Key: 286259851
• Report Number: MW5107645
• 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: Patient
• Type of Report: Initial
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian