MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-07 for ROM PLUS RUPTURE OF MEMBRANES TEST ROM-6025 manufactured by Clinical Innovations, Llc.
[101977978]
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.
Patient Sequence No: 1, Text Type: N, H10
[101977979]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2018-00003 |
| MDR Report Key | 7320712 |
| Date Received | 2018-03-07 |
| Date of Report | 2018-11-12 |
| Date Mfgr Received | 2018-02-19 |
| Date Added to Maude | 2018-03-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-03-07 |
| Model Number | ROM-6025 |
| Lot Number | J7007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-03-07 |