MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC ROM PLUS FETAL MEMBRABE RUPTURE TEST; IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S).

Model Number ROM-6025

Device Problem False Negative Result (1225)

Patient Problem Chorioamnionitis (1777)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

The stablished sensitivity for our rom product is 99% and based on complaint data, this is within the range expected.As the rupture happened the day before the test was conducted, chorioamnionitis is a known risk for patients with rupture membranes and this could have been present at the time the patient arrived at the hospital.Also, the test was read an hour after the sample was collected and our ifu clearly states that the results need to be read at 20 minutes.

Event Description

It was reported by a medical director that they had a false negative test that should have been positive.Patient developed chorioamnionitis from the prolonged ruptured membranes.

• Brand Name: ROM PLUS FETAL MEMBRABE RUPTURE TEST
• Type of Device: IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S).
• 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
• MDR Report Key: 6874732
• MDR Text Key: 87327969
• Report Number: 1722684-2017-00003
• Device Sequence Number: 1
• Product Code: NQM
• 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: distributor
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: ROM-6025
• Device Lot Number: 170436
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2018
• 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
• Patient Outcome(s): Other