MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-17 for CELLIENT PROCESSOR 71959-002 manufactured by Hologic Inc..
[109508263]
The customer reported observed abnormal cells that were not located in the 22 fovs selected by the imager. Cytology application specialist (cas) reviewed slide on the rsmp 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 the fovs. Cas reviewed this case and discussed with lab personnel. Cas agreed there were no changes seen in 22 fov to prompt an autoscan. Single sheet of lsil identified outside of fov. Please comment on the overall appearance of the slide: cellular, well prepared sample. Abnormal cells were discovered by the lab when: the case was discovered when doing 100% qc for new hire. Laboratory's interpretation of cells outside.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2018-00091 |
| MDR Report Key | 7523585 |
| Date Received | 2018-05-17 |
| Date of Report | 2018-04-18 |
| Date of Event | 2018-04-18 |
| Date Mfgr Received | 2018-04-18 |
| Date Added to Maude | 2018-05-17 |
| 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 | 0 |
| Brand Name | CELLIENT PROCESSOR |
| Generic Name | CELLIENT |
| Product Code | IDT |
| Date Received | 2018-05-17 |
| Model Number | 71959-002 |
| Lot Number | NA |
| 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 | 2018-05-17 |