MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-09-18 for ROM PLUS FETAL MEMBRABE RUPTURE TEST ROM-6025 manufactured by Clinical Innovations, Llc.
[87327969]
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.
Patient Sequence No: 1, Text Type: N, H10
[87327970]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2017-00003 |
| MDR Report Key | 6874732 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-09-18 |
| Date of Report | 2017-09-18 |
| Date of Event | 2017-05-08 |
| Date Mfgr Received | 2017-08-08 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2017-09-18 |
| 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 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 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROM PLUS FETAL MEMBRABE RUPTURE TEST |
| Generic Name | IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S). |
| Product Code | NQM |
| Date Received | 2017-09-18 |
| Model Number | ROM-6025 |
| Lot Number | 170436 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2017-09-18 |