MAUDE Adverse Event Report: QIAGEN SCIENCES, LLC AMNISURE ROM TEST

Model Number FMRT-1

Device Problem Failure of Device to Self-Test (2937)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

A maude report was communicated to qiagen that stated 3 test strips did not show a control line resulting in invalid tests.Customer returns were requested and tested along with company retain samples on (b)(6) 2018.The reported problem was confirmed with the customer's returned product where 5 out of 16 test strips tested had no visible control line.The reported problem was not confirmed with retained product where 25 out of 25 test strips tested all had visible control lines.All available inventory containing these test strips has been placed on hold until further investigation can be completed.

Event Description

On (b)(6), qiagen received from fda, medwatch report #(b)(4), which was submitted by (b)(6) hospital of (b)(6).The customer reported three invalid tests (no control line present) occured on (b)(6) 2018.

Manufacturer Narrative

Since the initial medical device report submission, qiagen has tested over 900 test strips from the complainant's kit lot, 557016546.To date, no invalid results have been observed on retained test strips, and 69 invalid results have been observed on test strips returned from customers and qiagen's third party logistics (3pl) location.This lot exhibits a higher than expected rate of invalid results.Qiagen has initiated a voluntary product recall of kit lots containing the same test strip lot (fmrt-1-25-us kit lots 55701646, 557016547, 5600115 and fmrt-1-25-ca kit lot 557016409).We are instructing customers to discontinue use of these lots and to return any unused inventory to qiagen.This field action was reported to ora as qiagen recall #1122376-05/18/2018-001r.Further updates will be provided to ora.The root cause for the invalid tests is still under investigation.

Event Description

On february 19th, qiagen received from fda, medwatch report #(b)(4), which was submitted by (b)(6).The customer reported three invalid tests (no control line present) occured on (b)(6) 2018.

• Brand Name: AMNISURE ROM TEST
• Type of Device: AMNISURE ROM TEST
• Manufacturer (Section D): QIAGEN SCIENCES, LLC; 19300 germantown road; germantown MD 20874
• MDR Report Key: 7346899
• MDR Text Key: 102720583
• Report Number: 1122376-2018-00003
• Device Sequence Number: 1
• Product Code: NQM
• Combination Product (y/n): N
• PMA/PMN Number: K081767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: FMRT-1
• Device Catalogue Number: FMRT-1-25-US
• Device Lot Number: 557016546
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1