MAUDE Adverse Event Report: PHAMATECH INC. COVID19 IGG / IGM RAPID TEST KIT; REAGENT, CORONAVIRUS SEROLOGICAL

Model Number WB/SERUM/PLASMA

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Virus (2136)

Event Date 05/25/2020

Event Type  malfunction  

Event Description

Diagnosed positive covid 19; (b)(6) 2020, prior to my vein ablation at (b)(6), they told me they needed to conduct testing for covid 19.They used the phamatech covid19 igg / igm rapid test kit.I asked them where they obtained these test kits and the nurse (male) who was administering the test told me the ceo of (b)(6) brought them in.(b)(6) is the operations manager.The first test came back positive for covid 19 i was told.They told me there was a faint hue of pink on the second line, igg line.I could barely see any pink hue on this line.I asked if i could take a picture of it.They said yes.I thought possibly the camera would pick up what i was not able to see w/ the naked eye.Nothing is visible from the camera photograph either.They said they had to do a second test because the first tests igg line was so slight.The second test came back as inconclusive.They did a third test and that came back negative.However, they cancelled the procedure.Insisting that i was covid 19 positive and reporting this to the health department.I would have to get a nasal pharyngeal swab test before i could return to work and that i was to remain isolated until the results from swab test could be confirmed.A friend had given me a ride to the doctor.They went out into the lobby and told him i was covid 19 positive.He immediately asked to be tested.They brought him into the same patient room w/ me and they obliged his request using the same rapid test kit from phamatech.His results were negative.I am on paid sick leave due to testing positive for covid 19.I have no symptoms.I have had my nasal swab performed at (b)(6) urgent care in (b)(6).Results will be in within 7-10 days.I did some research on the rapid test kit given by (b)(6).The test kit is prohibited from being marketed or distributed in the us as recent as 05/22/2020 according to the fda website-what tests should no longer be distributed for covid-19.I also found a link to phamatech's website that states this product is not to be distributed or marketed in the us due to the fda ruling.Yet (b)(6) was actively using it as of 1 pm on (b)(6) 2020.I am home now, alone.I will isolate until the test results from the nasal pharyngeal swab test are given to me.I remain asymptomatic and i suspect that i do not have covid 19 at all.I suspect (b)(6) will receive some form of grant or government stipend from my diagnosis.I have reported this information to my referring physician.I wonder how many more people (b)(6) is using this unauthorized test kit on? fda safety report id # (b)(4).

• Brand Name: COVID19 IGG / IGM RAPID TEST KIT
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): PHAMATECH INC.
• MDR Report Key: 10095903
• MDR Text Key: 192721340
• Report Number: MW5094701
• 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: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: WB/SERUM/PLASMA
• Device Catalogue Number: PART #2279
• Device Lot Number: D00633
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 86