MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-08-20 for THINPREP IMAGING SYSTEM manufactured by Hologic Inc..
[16433711]
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 support specialist (cas) reviewed slide on the review scope as an unk 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. There were two side by side cells each contained large koilocytes with binucleated hyperchromatic nuclei. The overall appearance of the slide was clean. Pt was a (b)(6) female, day 17 lmp; specimen was cervical. Abnormal cells were discovered by the lab when tech was scanning around after looking at the 22 fobs. Laboratory's interpretation of cells outside fov was lgsil-hpv. Cas interpretation of cells outside fov was lgsil-hpv. Site will be monitored to determine if expected occurrences (as determined by the pivotal study) are exceeded. Cytotechnologists on site will continued to hold questionable cases for cas review on next visit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2013-00156 |
| MDR Report Key | 3313765 |
| Report Source | 05,07 |
| Date Received | 2013-08-20 |
| Date of Report | 2013-08-01 |
| Date of Event | 2013-08-01 |
| Date Mfgr Received | 2013-08-01 |
| Date Added to Maude | 2013-09-05 |
| 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 | RANDALL COVILL, MANAGER |
| 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 | 2013-08-20 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-20 |