MAUDE Adverse Event Report: QIAGEN GMBH THERASCREEN® FGFR RGQ RT-PCR KIT; SOMATIC GENE MUTATION DETECTION SYSTEM

Catalog Number 1108661

Device Problem Signal Artifact/Noise (1036)

Patient Problems Diarrhea (1811); Keratitis (1944); Liver Damage/Dysfunction (1954); Stomatitis (4489); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/09/2022

Event Type  malfunction  

Event Description

A patient subject had been enrolled into a clinical study for erdafitinib based on a false positive result obtained with ref 1108661 therascreen fgfr rgq rt- pcr kit (iuo) and experienced side effects.

• Brand Name: THERASCREEN® FGFR RGQ RT-PCR KIT
• Type of Device: SOMATIC GENE MUTATION DETECTION SYSTEM
• 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: 15348243
• MDR Text Key: 305378213
• Report Number: 3004013603-2022-00004
• Device Sequence Number: 1
• Product Code: OWD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/02/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1108661
• Device Lot Number: 169047272
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1650-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other