MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC ROM PLUS RUPTURE OF MEMBRANES TEST

Model Number ROM-6025

Device Problem False Negative Result (1225)

Patient Problem Abscess (1690)

Event Type  Injury  

Manufacturer Narrative

We are in the process of doing a full investigation of this complaint.We have not received all of the clinical information from the facility to make a final conclusion, yet.Immunoassay tests are designed to be a tool for the clinician to use in conjunction with a patient assessment.Some things that could contribute to a false negative result or to the test result in this patient are listed below: · clinicians not following the ifu's.· patient rupture could have happened after rom plus test and prior to return to facility.· decreased amount of amniotic fluid (oligohydramnios).· potential high fluid leak of amniotic membranes.· patient with a more active vaginal proteases which breaks down protein more rapidly.We will continue our investigation and add any additional information that we receive from the facility to make a final conclusion.

Event Description

Reported that department (l&d) had three false negatives, one patient returned with maternal/fetal infection.(rumored after 48 hours).No other details reported as to gestation, gross rupture, etc.

Manufacturer Narrative

No product was returned and no customer photographs were provided.No further product evaluation could be performed in regard to this complaint.

Event Description

Reported that department (l&d) had three false negatives, one patient returned with maternal/fetal infection.(rumored after 48 hours).No other details reported as to gestation, gross rupture, etc.

• Brand Name: ROM PLUS RUPTURE OF MEMBRANES TEST
• Type of Device: RUPTURE OF MEMBRANES TEST
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 7320712
• MDR Text Key: 101977978
• Report Number: 1722684-2018-00003
• Device Sequence Number: 1
• Product Code: NQM
• UDI-Device Identifier: 00814247020857
• UDI-Public: 00814247020857
• Combination Product (y/n): N
• PMA/PMN Number: K110605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROM-6025
• Device Lot Number: J7007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization