MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2011-12-21 for NONE manufactured by .
[15578969]
.
Patient Sequence No: 1, Text Type: D, B5
[15943393]
On (b)(6) 2011, the (b)(6), reported 3 instances of amnisure rom test results not matching those from the older ferning method used by the facility. No specific pt info was shared at the time. (b)(6) informed us he had performed quality control on the assay and achieved expected results. A formal complaint was initiated by amnisure international despite the lack of pt info provided (b)(4). Over the following 10 days, there were 9 voicemails left by amnisure to obtain further info from the medical staff; none of which were answered by facility. After these failed attempts, amnisure successfully contacted (b)(6). He then reiterated that he did not have pt info available to share. After leaving 5 additional voicemails with no response, we reached (b)(6), on (b)(6) 2011. (b)(6) informed us at the time that an amnisure test result was positive when used on a (b)(6) gestational age (ga) pt who also had an amniotic fluid index (afi) of 0. She reported that this pt went on to deliver. We requested that (b)(6) provide us with any relevant info from this pt's chart since no specific pt info had been provided since the original report. She requested that we call her on (b)(6) 2011. During our follow up call on (b)(6) 2011, (b)(6) informed us that the amnisure test result for the (b)(6) ga pt discussed earlier was actually negative and purportedly resulted in a fetal demise. (b)(6) further commented that she was no longer concerned about this particular case and refused to provide further pt info pertinent to amnisure's investigation. (b)(6) went on to provide further details on the 2 remaining cases, for which investigations were then completed. (b)(6) refused to return the remaining amnisure inventory to us for quality control testing. Later on (b)(6) 2011, we contacted the clinical nurse specialist, (b)(6). (b)(6) said that amnisure was performed on the (b)(6) ga pt only and not on the other two pts. She also informed us that ferning was not used with the (b)(6) ga pt. During this call, she also reviewed the rupture of membranes eval protocol used by the facility. (b)(6) went on to say that both she and (b)(6) believed the nurses were not following the facility's rom diagnosis protocol. Finally, (b)(6) requested that amnisure visit the facility in (b)(6) and provide amnisure training for triage nurses. Several additional attempts were made to the facility between b)(6) 2011, but no info was obtained. Retain testing was performed on lot a1003 and results were shared with facility on (b)(6) 2011. On (b)(6) 2011, the medwatch report was received by amnisure's regulatory management representative. Since the facility no longer wanted to discuss the (b)(6) ga pt case or considered it a problem, 15 additional calls were made to gather more details. In communication on (b)(6) 2011, (b)(6), said she was surprised that a medwatch report was filed due to them believing the unexpected result was caused by user error and the internal protocol not being followed. (b)(6) was not able to provide pt info requested by amnisure. There is important info missing, such as how far in advance the pt ruptured before arriving at facility. According to the package insert, the amnisure rom test can provide negative results if the pt ruptured 12 hours prior to testing. Amnisure will continue to work with the facility to obtain pt data. Explanations of the negative results were discussed during the same call with (b)(6). The amniotic fluid index was 0 and the pt was reported to be dry, supporting that the negative result can best be explained by the lack of amniotic fluid for sampling. The pt returned to the hospital 6 hours after clinical eval with fever and infection. It is likely that the pt ruptured far in advance since infection does not usually set in that time frame. Devices from the same lot as the actual device reported were evaluated. The device performed according to specifications. No alleged failure could be duplicated and there seemed to be no defect in product performance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005345832-2011-00004 |
| MDR Report Key | 2393989 |
| Report Source | 00,06 |
| Date Received | 2011-12-21 |
| Date Mfgr Received | 2011-11-07 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2012-07-27 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL FRIEDMAN |
| Manufacturer Street | 24 SCHOOL ST 6TH FLOOR |
| Manufacturer City | BOSTON MD 02108 |
| Manufacturer Country | US |
| Manufacturer Postal | 02108 |
| Manufacturer Phone | 6172344441 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | NQM |
| Date Received | 2011-12-21 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-21 |