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

Model Number	ROM-6025
Health Effect - Clinical Code	Abscess (1690)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: RUPTURE OF MEMBRANES TEST
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 7320712
• Report Number: 1722684-2018-00003
• Device Sequence Number: 13482790
• Product Code: NQM
• UDI-Device Identifier: 00814247020857
• UDI-Public: 00814247020857
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: Health Professional
• Device Model Number: ROM-6025
• Device Lot Number: J7007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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