MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-08-24 for THINPREP IMAGING SYSTEM 70564-001 manufactured by Hologic Inc..
[83635237]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[83635238]
The customer reported observed abnormal cells that were not located in the 22 fovs selected by the imager. No triggers on the 22fovs to prompt an autoscan. Full review of slide during qc showed abnormal cells outside the fovs. Hologic cytology application specialist (cas) reviewed this case and discussed with lab personnel. Cas agreed there were no changes seen in 22fov to prompt an autoscan. There were three groups of koilocytes outside the fov. One was a cluster of 4 cells, the other a cluster of two cells, and the last group a sheet with koilocytotic changes. The overall appearance of the slide showed maturation with coccobacilli covering the squamous cells. The abnormal cells were found and the case was diagnosed as low grade squamous intraepithelial lesion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2017-00209 |
| MDR Report Key | 6817831 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-24 |
| Date of Report | 2017-07-26 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-07-26 |
| Date Added to Maude | 2017-08-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP IMAGING SYSTEM |
| Generic Name | AUTOMATED MICROSCOPE FOR CYTOLOGY |
| Product Code | MNM |
| Date Received | 2017-08-24 |
| Model Number | 70564-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-08-24 |