MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-03-06 for AMNISURE FMRT-1 FMRT-1-25-US manufactured by Amnisure International, Llc.
[5337645]
Patient arrived at the hospital on (b)(6) 2015. A visual exam of the vagina was completed; heavy yellow discharge was seen but no signs of amniotic fluid leakage. An amnisure test was performed and the result was negative. The patient was sent home. The patient returned to the hospital the net day and presented with a severe infection. Meconium was visible. The patient delivered and went into a septic shock. After delivery, the patient was placed in icu and administered antibiotics. The infant was also placed in nicu and administered antibiotics. Both patients recovered and were released from the hospital.
Patient Sequence No: 1, Text Type: D, B5
[13008677]
The company has evaluated this event and has determined that the result obtained from the device did not contribute or cause a serious injury to the patient. The company is submitting this mdr for information purposes in compliance with 21 cfr 803. The company will supplement this mdr with additional information, as necessary. Based on the information provided, it is highly suspected that designated parts of the procedure and limitations of the test were not followed. The healthcare facility reported that they are actively correlating amnisure with another diagnostic test for tom. The other test has a 15 second collection requirement, whereas amnisure has a 60 second collection. A nurse at this facility admitted to performing 15 second collections for both tests. While it is unconfirmed what the collection time was for the specific patient in question, it is likely that the collection time was shortened due to confusion when running the tests one after another. Additionally, the healthcare facility reviewed the patient chart and believes it is possible the patient reported signs of rupture more than 12 hours prior to testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005345832-2015-00001 |
| MDR Report Key | 4589123 |
| Report Source | 07 |
| Date Received | 2015-03-06 |
| Date of Report | 2015-03-06 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-02-05 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2015-03-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DONNA SOWERS |
| Manufacturer Street | 19300 GERMANTOWN RD. |
| Manufacturer City | GERMANTOWN MD 20874 |
| Manufacturer Country | US |
| Manufacturer Postal | 20874 |
| Manufacturer Phone | 2406867876 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMNISURE |
| Generic Name | RAPID FETAL MEMBRANES RUPTURE TEST |
| Product Code | NQM |
| Date Received | 2015-03-06 |
| Model Number | FMRT-1 |
| Catalog Number | FMRT-1-25-US |
| Lot Number | A353348 |
| ID Number | NA |
| Device Expiration Date | 2016-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMNISURE INTERNATIONAL, LLC |
| Manufacturer Address | 24 SCHOOL ST. 6TH FLOOR BOSTON MA 02108 US 02108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-03-06 |