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 12/29/2020

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.Investigation summary: in response to your complaint, we performed a search for similar complaints of the reported problem.No adverse trend was observed.Without product lot information, no further testing could be conducted.Although we were unable to duplicate your complaint, the information you provided has been documented and will continue to be monitored.Root cause: insufficient information.Source: email.

Event Description

Reported multiple false positive flu results on sofia flu+sars.The number of false positives is unknown.It is unknown if results pertained to flu a or flu b.It is unknown if the patients were symptomatic.Unknown if the result was confirmed.Confirmation method(s) not provided.Multiple attempts were made to contact the customer for more information.The customer was unable to provide further details and clarification.

• 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: 14528167
• MDR Text Key: 300130624
• Report Number: 0002024674-2022-05596
• 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: 05/27/2022

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: 12/29/2020
• Initial Date FDA Received: 05/27/2022
• 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