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

Model Number	ROM-5025
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/25/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: RUPTURE OF MEMBRANES TEST
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 7437905
• Report Number: 1722684-2018-00005
• Device Sequence Number: 16430873
• Product Code: NQM
• UDI-Device Identifier: 00814247020437
• UDI-Public: 00814247020437
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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
• Operator of Device: Nurse
• Device Expiration Date: 09/30/2020
• Device Model Number: ROM-5025
• Device Lot Number: 171749
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization