MAUDE Adverse Event Report: COVID 19 TESTING; REAGENT, CORONAVIRUS SEROLOGICAL

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Date 07/05/2020

Event Type  malfunction  

Event Description

I was tested on sunday, the 5th for covid-19.I was experiencing 0 (zero) symptoms.The urgent care center i went to, administered the rapid (bd max?) test.I came back positive.Due to myself not believing that i actually had the virus due to no symptoms, i opted for the second test (3 day test) to confirm.The second test was not offer to me, i had to ask.This test result came back negative.I was told by the medical professionals at the urgent care center to trust my negative test and to contact the health dept because i was a false positive.The health dept.In (b)(6), told me that i was still a positive to them.I was told the rapid test was more accurate, but my medical professional told me it was not.Which has been proven by the fda's statement today.My more advanced test that showed negative didn't matter.The state of (b)(6) would not correct the positive case.So for the past three days, i've been quarantined with actual positive cases and actually been negative the whole time.Thankfully, i have a room to myself and wear a mask when i leave the room and keep distance.I still show no symptoms.However, this is ridiculous.How can false positives not be recognized? how am i still required to be considered positive and sign a paper saying so? there are 94 cases in my county.If my false positive and possibly more could be revoked there would be less.Thankfully, before i was tested i was not around anyone to be contacted by tracing.But if i had, those would have been out of work with no pay for 14 days all because of a false positive test.I have contacted the health dept, (b)(6) covid hotline, and the dept.Of public health and all have told me "they don't know what to tell me except that i'm positive to them".Excuse me, what? how do medical professionals and covid experts not know? something has to be done to fix this.I am beyond upset.(b)(6) is doing the worst possible thing to it's citizens, which is lying.I do not feel this is right.How does (b)(6) not recognize false positives when the fda warns about them? i hope i am contacted back about this.Because i'm sure i've left bits and pieces out.Please contact me at (b)(6).Fda safety report id# (b)(4).

• Brand Name: COVID 19 TESTING
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• MDR Report Key: 10263397
• MDR Text Key: 198696234
• Report Number: MW5095482
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 66