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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: a review of complaint history did not identify any adverse trends.Root cause: insufficient information source: phone.

Event Description

Reported false positive (specific analytes unknown) results for an unknown number of patients.It is unknown if the patients were symptomatic or is the results were confirmed.Confirmation method(s) not provided.Multiple attempts were made to contact the customer for more information.The customer was unresponsive.

• 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: 15971471
• MDR Text Key: 306519210
• Report Number: 0002024674-2022-10601
• 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: 12/13/2022

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: 11/30/2022
• Initial Date FDA Received: 12/13/2022
• 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