MAUDE Adverse Event Report: DIAGNOSTIC HYBRIDS, INC. SOLANA SARS-COV-2 ASSAY (FRZ MMX)

Model Number	Coronavirus
Medical Device Problem Codes	False Negative Result (1225); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: retain test of the #218542 kit resulted in expected results.Unable to duplicate customer complaint.Root cause for false negatives is unable to be determined through retain testing root cause: no problem found;unable to determine.Source: phone.
Event or Problem Description
Reported false negative sars result.The customer communicated the result was positive by another molecular method.

• Brand Name: SOLANA SARS-COV-2 ASSAY (FRZ MMX)
• Common Device Name: SOLANA SARS-COV-2 ASSAY (FRZ MMX)
• Manufacturer (Section D): DIAGNOSTIC HYBRIDS, INC.; 2005 east state street; suite 100; athens OH 45701
• Manufacturer Contact: karl luke ; 2005 east state street; suite 100; athens, OH 45701 ; 7405893382
• MDR Report Key: 15227085
• Report Number: 0002024674-2022-08686
• Device Sequence Number: 14915799
• Product Code: QJR
• UDI-Device Identifier: 30014613339656
• UDI-Public: 30014613339656
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/12/2022

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: 218542
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/15/2022
• 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