MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-29 for AMNISURE ROM TEST FMRT-1 FMRT-1-25-US manufactured by Qiagen Sciences, Llc.
[147463482]
Customer reported that patient had been using interfering substances prior to sample collection. Customer was informed that topical medications can interfere with test performance as stated in the product package insert. No death, serious injury/illness or deterioration of health occured. Based on all clinical information available, patient was admitted and successfully delivered. Initial internal testing confirmed one false negative result and further investigation is pending. Customer results may have been affected by use of topical medications. In an abundance of caution this incident is being reported. The amnisure test is for use by healthcare professionals to aid in the diagnosis of rom in pregnant women reporting signs, symptoms or complaints suggestive of rom. Results should be used in conjunction with other clinical information and negative results alone may not rule out a membrane rupture.
Patient Sequence No: 1, Text Type: N, H10
[147463483]
Customer reported false negative result for one patient that had used hydrocortizone and benzocaine at an unknown timeframe prior to testing. Patient was in active labor and successfully delivered 9 hours later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122376-2019-00001 |
| MDR Report Key | 8559917 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-29 |
| Date of Report | 2019-04-24 |
| Date Mfgr Received | 2019-03-25 |
| Device Manufacturer Date | 2017-08-24 |
| Date Added to Maude | 2019-04-29 |
| 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 | MS. DONNA SOWERS |
| Manufacturer Street | 19300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN 20874 |
| Manufacturer Country | US |
| Manufacturer Postal | 20874 |
| Manufacturer Phone | 2406867876 |
| Manufacturer G1 | QIAGEN SCIENCES, LLC |
| Manufacturer Street | 19300 GERMANTOWN ROAD |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 20874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMNISURE ROM TEST |
| Generic Name | AMNISURE ROM TEST |
| Product Code | NQM |
| Date Received | 2019-04-29 |
| Model Number | FMRT-1 |
| Catalog Number | FMRT-1-25-US |
| Lot Number | 557017538 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QIAGEN SCIENCES, LLC |
| Manufacturer Address | 19300 GERMANTOWN ROAD GERMANTOWN MD 20874 US 20874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-29 |