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

Model Number FMRT-1

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2019 customer reported unexpected negative amnisure results for 3 patients with no adverse outcomes.Additional information and return product was requested from customer.Follow up information was received 1/28/2020.The malfunction was not confirmed on returned material, however was observed in retained product testing at a rate within the labeled performance characteristics of the product.No other customers have reported issues with this lot.Qiagen's overall evaluation does not indicate a systemic problem with this lot.

Event Description

A customer reported patient in labor, grossly ruptured, ferning and pooling positive, and amnisure negative.Patient admitted and successfully delivered.

• Brand Name: AMNISURE ROM TEST
• Type of Device: AMNISURE ROM TEST
• Manufacturer (Section D): QIAGEN SCIENCES, LLC; 19300 germantown rd; germantown, md
• Manufacturer (Section G): QIAGEN SCIENCES, LLC; 19300 germantown road; germantown, md
• Manufacturer Contact: donna sowers ; 19300 germantown road; germantown, md ; 6867876
• MDR Report Key: 9730230
• MDR Text Key: 188701768
• Report Number: 1122376-2020-00002
• Device Sequence Number: 1
• Product Code: NQM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: FMRT-1
• Device Catalogue Number: FMRT-1-25-US
• Device Lot Number: 56307021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2019
• 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