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

Model Number	Coronavirus
Medical Device Problem Codes	False Positive Result (1227); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reporting suspected false positive sars result.Customer communicated the issue is occurring over several instruments and with negative controls (each patient event will be filed separately).Symptomatic status of patient is unknown and no confirmation testing was performed.
Additional Manufacturer Narrative
Investigation conclusion: review of all information provided indicates temperature monitoring equipment failures and environmental cross contamination at site.New equipment and troubleshooting information on how to reduce false positives due to environmental cross contamination was provided by onsite quidel personnel.No further investigation of product is needed.Root cause: contamination / customer equipment failure.Source: phone.

• Brand Name: SOLANA SARS-COV-2 ASSAY (FRZ MMX)
• Common Device Name: SOLANA SARS-COV-2 ASSAY (FRZ 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: 15090022
• Report Number: 0002024674-2022-09139
• Device Sequence Number: 17405471
• Product Code: QJR
• UDI-Device Identifier: 30014613339656
• UDI-Public: 30014613339656
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EUA203087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2022

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
• Operator of Device: Health Professional
• Device Model Number: Coronavirus
• Device Catalogue Number: M313
• Device Lot Number: 213475, 212561
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown