MAUDE Adverse Event Report: CORDX, INC. CORDX TYFAST FLU A/B & COVID-19 MULTIPLEX RAPID TEST

Model Number	ACT21002-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Eua no: (b)(4).On october 10th, a provider from (b)(6) reported multiple false positive results while using our 3-in-1 poc tests.Approximately half of a 25t box from batch number us2429810 was used.Investigation summary: a review of the complaint history showed no adverse trends related to this issue.The device history record (dhr) for lot us2429810 was reviewed, and no discrepancies were found.Retention samples were tested, and all results met qc release criteria.The false positive rate was within the expected range, and the root cause could not be determined at this time.We will continue to monitor the trend closely.
Event or Problem Description
On october 10th, a provider from (b)(6) raised a complaint regarding multiple false positive results observed while using cordx tyfast flu a/b & covid-19 multiplex rapid test poc tests.Approximately half of a box of 25t tests from batch number us2429810 was used.Multiple tests showed positive results for both flu a and flu b, even in asymptomatic patients.Some tests showed simultaneous positive results for flu a/b and covid-19.

• Brand Name: CORDX TYFAST FLU A/B & COVID-19 MULTIPLEX RAPID TEST
• Common Device Name: CORDX TYFAST FLU A/B & COVID-19 MULTIPLEX RAPID TEST
• Manufacturer (Section D): CORDX, INC.; 9540 waples st unit c; san diego, CA 92121
• Manufacturer (Section G): CORDX INC.; 9540 waples st unit c; san diego, CA 92121
• Manufacturer Contact: ethan loh ; 9540 waples st unit c; san diego, CA 92121
• MDR Report Key: 20638454
• Report Number: 3012234563-2024-00002
• Device Sequence Number: 17984411
• Product Code: QMN
• UDI-Device Identifier: 00850042559635
• UDI-Public: 00850042559635
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2025
• Device Model Number: ACT21002-25
• Device Lot Number: US2429810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown