MAUDE Adverse Event Report: QIAGEN GMBH THERASCREEN EGFR RGQ PCR KIT

Model Number 1

Device Problem Insufficient Information (3190)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Although no injury was reported, a false positive result reported to the physician could cause injury to the patient.Qiagen is reporting this incident in an abundance of caution.Qiagen does not know how the result was used to guide the patient's treatment or the status of the patient.

Event Description

Customer obtained a false positive g719x result using the test and reported it to the physician.Treatment and status of patient unknown.No injury reported.

• Brand Name: THERASCREEN EGFR RGQ PCR KIT
• Type of Device: THERASCREEN EGFR RGQ PCR KIT
• 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: lindsey howard ; 19300 germantown rd; germantown, md ; 6867826
• MDR Report Key: 9845345
• MDR Text Key: 196409950
• Report Number: 3004013603-2020-00002
• Device Sequence Number: 1
• Product Code: OWD
• UDI-Device Identifier: 04053228002062
• UDI-Public: 04053228002062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Model Number: 1
• Device Catalogue Number: 870121
• Device Lot Number: 163035334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other