MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-17 for ROM PLUS RUPTURE OF MEMBRANES TEST ROM-5025 manufactured by Clinical Innovations, Llc.
[105761452]
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.
Patient Sequence No: 1, Text Type: N, H10
[105761453]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2018-00005 |
| MDR Report Key | 7437905 |
| Date Received | 2018-04-17 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-02-25 |
| Date Mfgr Received | 2018-03-20 |
| Device Manufacturer Date | 2017-11-28 |
| Date Added to Maude | 2018-04-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SANTOSH BHAGAT |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012688200 |
| Manufacturer G1 | CLINICAL INNOVATIONS, LLC |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROM PLUS RUPTURE OF MEMBRANES TEST |
| Generic Name | RUPTURE OF MEMBRANES TEST |
| Product Code | NQM |
| Date Received | 2018-04-17 |
| Model Number | ROM-5025 |
| Lot Number | 171749 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS, LLC |
| Manufacturer Address | 747 W 4170 S MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-04-17 |