MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-04-15 for THINPREP IMAGING SYSTEM manufactured by Hologic Inc.
[18302562]
No delay in pt diagnosis. Customer reported a group of hsil cells were outside of the 22 fields of view (fov) and there were no abnormal cells found in any of the 22 fovs. Cytology applications specialist confirmed the imager miss. Pt had previous case of hsil; therefore ,a full scan of the slide was completed. Customer agreed imager operated as expected and did not want to proceed any further.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2014-00060 |
| MDR Report Key | 3775328 |
| Report Source | 05,06 |
| Date Received | 2014-04-15 |
| Date of Report | 2014-03-27 |
| Date Mfgr Received | 2014-03-27 |
| Date Added to Maude | 2014-04-29 |
| 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 | CHRISTINA PAUL |
| Manufacturer Street | 445 SIMARANO DR |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| 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 | 2014-04-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INC |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-15 |