MAUDE Adverse Event Report: QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS QKVUE SARS AG HOME

Catalog Number	20402
Medical Device Problem Codes	False Positive Result (1227); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reports 9 false positives.Unknown if symptomatic or asymptomatic.Results interpreted after read time.Report 2 of 9.
Additional Manufacturer Narrative
Investigation conclusion: a review of the package insert (pi) was conducted for clarity of instructions.No issues were found.The customer's reported problem was related to a deviation from the instructions called out in the pi.Root cause: customer procedural error source: phone.

• Brand Name: QKVUE SARS AG HOME
• Common Device Name: QKVUE SARS AG HOME
• Manufacturer (Section D): QUIDEL CORPORATION DBA ORTHO-CLINICAL DIAGNOSTICS; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: chelsea lindgren ; 10165 mckellar court; san diego, CA 92121
• MDR Report Key: 20785479
• Report Number: 0002024674-2024-00883
• Device Sequence Number: 13024908
• Product Code: QKP
• UDI-Device Identifier: 30014613339724
• UDI-Public: (01)30014613339724(10)000263(17)251024
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EUA210269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 10/24/2025
• Device Catalogue Number: 20402
• Device Lot Number: 000263
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/26/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown