MAUDE Adverse Event Report: QUIDEL CORPORATION SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB

Catalog Number 20377

Device Problems False Positive Result (1227); No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: a review of the product did not find any unusual trend for the reported complaint category.Without a lot number, no further investigation can be conducted.Root cause: insufficient information.Source: email.

Event Description

Reported an increase in false positive flu results on sofia flu+sars.Number of results is unknown.Unknown if the result was confirmed.Confirmation method(s) not provided.

• Brand Name: SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB
• Type of Device: SOFIA2 FLU + SARS ANTIGEN FIA, NS SWAB
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar ct.; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar ct.; san diego, CA 92121 ; 7405893382
• MDR Report Key: 14570011
• MDR Text Key: 295506096
• Report Number: 0002024674-2022-06082
• Device Sequence Number: 1
• Product Code: QMN
• UDI-Device Identifier: 30014613339229
• UDI-Public: 30014613339229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA202751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 20377
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 06/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1