MAUDE Adverse Event Report: DIAGNOSTIC HYBRIDS, INC. DBA ORTHO-CLINICAL DIAGNO SOLANA SARS-COV-2 ASSAY (LYO MMX)

Catalog Number	M312
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	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported false positives.Tss worked with customer and came to the conclusion that the false positives were due to environmental/carry-over contamination.Customer fixed problem and has reported no further issues.No further investigation is required.Source of complaint was a phone call.
Event or Problem Description
Customer reported 5 false positive patient results.No confirmatory testing was performed.Issue resolved by decontamination.

• Brand Name: SOLANA SARS-COV-2 ASSAY (LYO MMX)
• Common Device Name: SOLANA SARS-COV-2 ASSAY (LYO MMX)
• Manufacturer (Section D): DIAGNOSTIC HYBRIDS, INC. DBA ORTHO-CLINICAL DIAGNO; 2005 east state street; athens OH 45701
• Manufacturer Contact: chelsea lindgren ; 2005 east state st; athens, OH 45701
• MDR Report Key: 20561250
• Report Number: 0002024674-2024-00682
• Device Sequence Number: 2987893
• Product Code: QJR
• UDI-Device Identifier: 30014613339427
• UDI-Public: (01)30014613339427
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/29/2024

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 Catalogue Number: M312
• Device Lot Number: 253511
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/29/2024
• 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