MAUDE Adverse Event Report: QUIDEL CORPORATION QUICKVUE; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem False Positive Result (1227)

Patient Problems Hypersensitivity/Allergic reaction (1907); Viral Infection (2248)

Event Type  malfunction  

Event Description

Had dozens of false positive tests with quidel quickvue from mid- to late (b)(6) through early (b)(6) after infection acquired from lab member on 2022.Had been boosted 11 months before infection, which was mild.First tested negative by binaxnow approximately 10 days after infection (roughly seven days after symptom onset).Continued to test positive by quidel quickvue in late (b)(6), through (b)(6), and in early (b)(6).(was testing nearly every other day in (b)(6) and early (b)(6).Went on paxlovid (b)(6) and got a bivalent booster on (b)(6) 2022.No known immune conditions and had had normal cbc(complete blood count) on "(b)(6)." finally confirmed these were false positives by testing repeatedly negative with flowflex and qpcr with ct threshold of 40 in (b)(6).Colleague of mine participating in nih radx program says this is a known but unpublished result with some speculated mechanisms that imo(intelligent medical objects) are not unsurprising.I have photo records of me testing negative on quickvue in (b)(6) 2022 (and positive repeatedly this fall).I am infectious disease researcher working on sars-cov-2 and happy to share more details, this severely impacted my life and work.Please contact me for complete dates for all the likely false positive tests.I have photos with many of the batch numbers, negative results, etc., although i threw out the used test strips.During period of false positives, was on topical tretinoin nightly.Took prednisone (60 mg-40-40-20-20) (b)(6) 2022 to deal with hives from delayed allergic reaction at radial insertion site for uterine fibroid embolization on (b)(6) alarmed i was still testing positive by quidel quickvue, i convinced pcp(primary care provider) to prescribe paxlovid (b)(6).I continued to test positive and allergic reaction returned, so i started using triamcinolone at wrist for approximately 10 days.Still testing positive by quidel quickvue, i got my bivalent booster on (b)(6) 2022.I continued to test positive well into (b)(6) and stopped testing after multiple negative (q)pcr and flowflex tests.During period of false positives, using only vegan omega 3 supplements, ferrous bisglycinate (28 mg/day) w/ folate, vitamin c and, b12 supplement.

• Brand Name: QUICKVUE
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 16121591
• MDR Text Key: 306990398
• Report Number: MW5114212
• Device Sequence Number: 1
• 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: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: DURING PERIOD OF FALSE POSITIVES, WAS ON TOPICAL TRETINOIN NIGHTLY
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White