MAUDE Adverse Event Report: QUIDEL CORPORATION SOLANA SARS-COV-2 ASSAY (LYO MMX)

Catalog Number M312

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: to be determined root cause: to be determined source: email.

Event Description

Customer is experiencing false positive sars results.All customer negative qc controls are also resulting positive.Contamination or assay technique is suspect.

Manufacturer Narrative

Updates made: b4; date of report ; updated to today's date.G6 ; follow-up 1.Updates to manufacturers narrative: investigation conclusion: retain testing performed for the m312 solana sars-cov-2 assay lot #220875 in accordance with qc qualification procedures.Customer results could not be duplicated.Root cause: unable to determine.Source: phone.

• Brand Name: SOLANA SARS-COV-2 ASSAY (LYO MMX)
• Type of Device: SOLANA SARS-COV-2 ASSAY (LYO MMX)
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar court; san diego CA 92121
• Manufacturer Contact: karl luke ; 10165 mckellar court; san diego, CA 92121 ; 7405893382
• MDR Report Key: 16414959
• MDR Text Key: 309982069
• Report Number: 0002024674-2023-00421
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA203087
• 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,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M312
• Device Lot Number: 220875
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• 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