MAUDE Adverse Event Report: QIAGEN SCIENCES, LLC QUANTIFERON; QUANTIFERON TB PLUS ELISA

Catalog Number	622130
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient claim harm resulting from treatement for posiitive qft plus and ppd results.Insufficient information was provided for a comprehensive investigation.As stated in the ifu, qft-plus is an indirect test for m.Tuberculosis infection (including disease) and is intended for use in conjuction with risk assessment, radiography and other medical and diagnostic evaluations.
Event or Problem Description
Alleged false positive with quantiferon tb plus elisa, leading to unnecessary treatment and serious medical consequence.

• Brand Name: QUANTIFERON
• Common Device Name: QUANTIFERON TB PLUS ELISA
• Manufacturer (Section D): QIAGEN SCIENCES, LLC; 19300 germantown rd; germantown MD 20874
• Manufacturer (Section G): QIAGEN SCIENCES, LLC; 19300 germantown road; germantown MD 20874
• Manufacturer Contact: donna sowers ; 19300 germantown road; germantown, MD 20874 ; 2405067195
• MDR Report Key: 19132630
• Report Number: 1122376-2024-00001
• Device Sequence Number: 15176282
• Product Code: NCD
• UDI-Device Identifier: 04053228015864
• UDI-Public: 04053228015864
• Combination Product (Y/N): N
• PMA/510(K) Number: P010033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 622130
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female