MAUDE Adverse Event Report: QUIDEL CORP. SOFIA INFLUENZA A+B; DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2021

Event Type  No Answer Provided  

Event Description

Six (6) errors involving the quidel sars and influenza a+b; effected 3 pt.'s each in 2 separate departments.Inadvertently, the influenza tests were restocked with the sars tests; staff performing the tests did not recognize any change/difference in the product individual package, thus performing the influenza test and documenting as a covid result; each of these had to be marked invalid in the pt record; each pt was notified and brought back for correct test and documented the accurate results.Sent this to quidel customer service email letter attached below.Identified areas of concern and request consideration of product package changes: the quidel sars antigen and influenza a+a boxes, holding 25 tests each are very similar in appearance.The colors are different, but overall design resembles each other; the individually wrapped tests are very difficult to distinguish one from the other; only the very small print on the packaging identifies the type of test; the identifying test type is on the folded edge of the package.Fda safety report id # (b)(4).

• Brand Name: SOFIA INFLUENZA A+B
• Type of Device: DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 12210561
• MDR Text Key: 263235077
• Report Number: MW5102679
• Device Sequence Number: 2
• Product Code: PSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/19/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR