MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-06-20 for THINPREP IMAGING SYSTEM manufactured by Hologic Inc.
[3515427]
Lab personnel reported a case with observed abnormal cells that were not located in the 22 fields of view (fov) selected by the imager. Cytology application specialist (cas) reviewed slides on the review scope as an unknown mixed with other slides. Two cases presented had no triggers in the 22 fobs to prompt an autoscan. Full review of slide during qc showed abnormal cells outside the fovs. Cas reviewed this case and discussed with lap personnel. Cas agreed there were no changes seen in 22 fov to prompt an autoscan. Please comment on number of abnormal cells present: rare. Please comment on the overall appearance of the slide: (b)(6): the background of the slide was cytolysis there was one group of lsil; (b)(6): the background was clean with superficial and intermediate cells. There was one large keratinized cell with a large abnormal nucleus. The nucleus looked a little degenerate. Customer did not request slide to be reviewed at corporate. Customer will continue to hold questionable cases for cas review. Customer did not require follow up from customer support services.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2013-00125 |
| MDR Report Key | 3187970 |
| Report Source | 05 |
| Date Received | 2013-06-20 |
| Date of Report | 2013-05-21 |
| Date of Event | 2013-05-21 |
| Date Mfgr Received | 2013-05-21 |
| Date Added to Maude | 2013-06-27 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RANDALL COVILL, MGR |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638853 |
| Single Use | 0 |
| 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 | 2013-06-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INC |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2013-06-20 |