MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-25 for THINPREP IMAGING SYSTEM manufactured by Hologic Inc.,.
[4535354]
Possible false negative. Lab reported three (3) cases in which abnormal cells found outside of 22 fields of view (fov). No abnormal cells were present within the 22 fov to prompt full autoscan of the slide. The abnormal cells were found outside the fov during qc. Site will be monitored to determine if expected occurrences are exceeded. Hologic will schedule a full imager prep review with the laboratory. This incident is classified as a rare event, which is where the cells in question would match our experience in the clinical trial as evidenced in table 8 of the thinprep imaging system operating summary and clinical information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2014-00112 |
| MDR Report Key | 3949350 |
| Report Source | 06 |
| Date Received | 2014-06-25 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-01-01 |
| Date Added to Maude | 2014-07-23 |
| 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 | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638912 |
| Single Use | 3 |
| 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 | 2014-06-25 |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Other | 2014-06-25 |