MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-26 for THINPREP IMAGING SYSTEM manufactured by Hologic, Inc..
[39231777]
Possible false negative. Per hologic's cytology applications specialist (cas) a customer's lab personnel reported a case with observed abnormal cells that were not located in the 22 fovs selected by the imager. Cas reviewed slide on the review scope as an unknown mixed with other slides. Case presented had no triggers in the 22 fovs to prompt an autoscan. Full review of slide during qc showed abnormal cells outside. Case was picked up on qc. There were two groups of hsil cells on the slide, with no abnormal cells in the 22 fov. The customer would like to submit the slide for internal review though the cas explained they would not receive a report. This is a reportable event in the us as this is a potential delay in diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00043 |
| MDR Report Key | 5463602 |
| Date Received | 2016-02-26 |
| Date of Report | 2016-02-25 |
| Date Mfgr Received | 2016-02-03 |
| Date Added to Maude | 2016-02-26 |
| 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 | MS EVA MAXWELL |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH, MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THINPREP IMAGING SYSTEM |
| Generic Name | AUTOMATED MICROSCOPE FOR CYTOLOGY |
| Product Code | MNM |
| Date Received | 2016-02-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-26 |