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

Model Number ROM-5025

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Date 02/25/2018

Event Type  Injury  

Manufacturer Narrative

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 positive result or to the test result in this patient are listed below: · clinicians not following the ifu's obtaining the sample or performing the test.· patient could have ruptured a forebag causing the test to be positive.· high fluid leak of amniotic membranes.· very small leak of amniotic fluid, and the membranes resealed.Clinical innovations will continue to investigate this event and follow up if any other information is obtained.

Event Description

Patient had a positive when the rom plus test was used.The patient was induced and ultimately taken for a c-section.During the c-section the physician had to rupture the membranes.The baby was taken to the nicu due to issue from being premature.

• 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
• Manufacturer (Section G): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: santosh bhagat ; 747 w 4170 s; murray, UT 84123 ; 8012688200
• MDR Report Key: 7437905
• MDR Text Key: 105761452
• Report Number: 1722684-2018-00005
• Device Sequence Number: 1
• Product Code: NQM
• UDI-Device Identifier: 00814247020437
• UDI-Public: 00814247020437
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 09/30/2020
• Device Model Number: ROM-5025
• Device Lot Number: 171749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization