MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-27 for BD FOCALPOINT? SLIDE PROFILER 490652 manufactured by Tripath Imaging, Inc.
[48305401]
(b)(4). The bd focalpoint? Slide profiler is an automated cervical cytology screening device intended for use in initial screening of cervical cytology slides. The pap test is a screening test for cervical cytology specimens. According to the bethesda system for reporting cytology, while endocervical adenocarcinomas may be directly sampled, the detection of endometrial adenocarcinoma depends on exfoliated cells being present in the collected specimen. Qc review of the 2015 surepath slide shows the presence of 10 to 12 atypical endometrial groups (cannot exclude adenocarcinoma). Bd quality has reviewed the complaint of one false negative, case of endometrial adenocarcinoma that was called? No further review? (nfr) on the focal point. The data provided by the customer was reviewed by bd. Based on the number of slides classified as nfr in july 2015 (n= (b)(4)), it was agreed that the false negative result obtained is within the instrument clinical performance claims. Review of the data also revealed no indication of an instrument mechanical issue during the time frame where the false negative result was obtained. No trend is identified for false negative complaints at this time. Bd will continue to monitor. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[48305402]
Patient slide was processed by the focalpoint as no further review (nfr) on (b)(6) 2015. The case was reported to physician as nfr. Nfr results are treated as a negative result. Patient underwent a endometrial biopsy on (b)(6) 2016 and the cytology pap test was repeated on (b)(6) 2016. The pathologist diagnosis for cytology and histology was endometrial adenocarcinoma. The malignant diagnosis triggered a review of the previous negative slide. The slide was pulled and reviewed manually by two senior cytotechnologists and classified as endometrial adenocarcinoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004173866-2016-00001 |
| MDR Report Key | 5752626 |
| Date Received | 2016-06-27 |
| Date of Report | 2016-06-27 |
| Date of Event | 2015-07-09 |
| Date Mfgr Received | 2016-05-30 |
| Device Manufacturer Date | 2009-03-20 |
| Date Added to Maude | 2016-06-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX CAROL NIETO |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164000 |
| Manufacturer G1 | TRIPATH IMAGING, INC |
| Manufacturer Street | 1022 CORPORATE PARK DRIVE |
| Manufacturer City | MEBANE NC 27302 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27302 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD FOCALPOINT? SLIDE PROFILER |
| Generic Name | FOCAL POINT SLIDE PROFILER |
| Product Code | MNM |
| Date Received | 2016-06-27 |
| Catalog Number | 490652 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRIPATH IMAGING, INC |
| Manufacturer Address | 1022 CORPORATE PARK DRIVE MEBANE NC 27302 US 27302 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2016-06-27 |