MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-24 for BD FOCALPOINT SLIDE PROFILER 799-00256-14R manufactured by Tripath Imaging, Inc..
[16375609]
The false negative that resulted led to a delay of diagnosis. To date, bd has not confirmed the medical and surgical intervention taken to preclude serious injury. Internal review of the device false negative rate showed that the device performed within labeling claim as intended. No field safety corrective actions are planned as a result of this complaint.
Patient Sequence No: 1, Text Type: N, H10
[16437900]
The customer contacted technical support via email stating that "i have a high grade miss from fp037 in 2011". Technical support contacted the customer site to ask about the false negative hgsil. The customer explained that a repeat pap was done this year, which resulted in a hsil. A retrospective review was performed for the 2011 sample which also showed a hsil result. The 2011 report was amended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062336-2013-00006 |
| MDR Report Key | 3133075 |
| Report Source | 05,06 |
| Date Received | 2013-05-24 |
| Date of Report | 2013-04-26 |
| Date Mfgr Received | 2013-04-26 |
| Device Manufacturer Date | 1999-07-01 |
| Date Added to Maude | 2013-05-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE BINION, DIR |
| Manufacturer Street | 4025 STIRRUP CREEK DR STE 400 |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9192067158 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD FOCALPOINT SLIDE PROFILER |
| Generic Name | FOCALPOINT |
| Product Code | MNM |
| Date Received | 2013-05-24 |
| Catalog Number | 799-00256-14R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRIPATH IMAGING, INC. |
| Manufacturer Address | 780 PLANTATION DR. BURLINGTON NC 27215 US 27215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-24 |