MAUDE Adverse Event Report: QIAGEN GMBH QIASYMPHONY SP; CLINICAL SAMPLE CONCENTRATOR

Catalog Number	9001297
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Delayed results due to instrument malfunction.
Additional Manufacturer Narrative
No adverse outcomes were reported.This incident is being reported in an abundance of caution.

• Brand Name: QIASYMPHONY SP
• Common Device Name: CLINICAL SAMPLE CONCENTRATOR
• Manufacturer (Section D): QIAGEN GMBH; qiagen strasse 1; hilden, nrw 40724 ; GM 40724
• Manufacturer (Section G): QIAGEN GMBH; qiagen strasse 1; hilden, nrw 40724 ; GM 40724
• Manufacturer Contact: davide manissero ; skelton house; lloyd street north; manchester, MA5 6-SH ; UK MA5 6SH
• MDR Report Key: 19461880
• Report Number: 3005118020-2024-00001
• Device Sequence Number: 12465530
• Product Code: JJH
• UDI-Device Identifier: 04053228010739
• UDI-Public: 04053228010739
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: 9001297
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown