MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-09-18 for THINPREP IMAGING SYSTEM manufactured by Hologic Inc.
[3777065]
Customer reported low grade diagnostic cells seen outside field of view (fov) on one or two slides a month. Customer informed field service engineer (fse) that this imager missed 2 cases that had koilocytes, low grade cells. These were outside of the 22 fovs and were missed by the imager. Fse spoke with customer (tracy davidson). She reported 2 cases that had diagnostic koilocytes low grade cells that were not picked up by this imager and were not in fov while screening these slides on the review scope. Fse reviewed error log and run reports. Fse did not find any errors or events relating to this complaint or that would be an issue not to operate the instrument. Fse cleaned optics path and performed all optics set-ups per technical documentation. Imager passed verification slide test and imaged services slides with no events. Imager is operational.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2013-00177 |
| MDR Report Key | 3397124 |
| Report Source | 06 |
| Date Received | 2013-09-18 |
| Date of Report | 2013-08-22 |
| Date of Event | 2013-08-22 |
| Date Mfgr Received | 2013-08-22 |
| Date Added to Maude | 2013-11-04 |
| 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, 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 | 2013-09-18 |
| 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 | 2013-09-18 |