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)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, cordx inc.Received feedback from bdsc (distributor), stating that there were false positive results reported (flu a and flu b) with cordx tyfast flu a/b & covid-19 multiplex rapid test by end users.End users performed re-test using another manufacturer test kits and the results were negative.The actual date of the testing was not provided.No images or raw data for the testing results could be shared with cordx to assess.
Additional Manufacturer Narrative
Eua no: (b)(4) distributor feedback on (b)(6) 2024, user received flu a and flu b positive result however, repeat test using another manufacturer test kit was negative.No health impact or consequence reported.Investigation summary: a review of complaint history did not identify any adverse trends for the reported issue.Lot number us2415801 device history record (dhr) was reviewed and no discrepancies were found.Retention samples were tested, all testing meet qc release criteria.Unable to determine the rootcause.Will continue to monitor the trend.

• 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 Contact: ethan loh ; 9540 waples st unit c; san diego, CA 92121
• MDR Report Key: 19631036
• Report Number: 3012234563-2024-00001
• Device Sequence Number: 15605844
• Product Code: QMN
• UDI-Device Identifier: 00850042559635
• UDI-Public: 00850042559635
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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: 01/09/2025
• Device Model Number: ACT21002-25
• Device Lot Number: US2415801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown