MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-07-09 for THINPREP IMAGING SYSTEM manufactured by Hologic Inc.
[18071541]
No delay in patient diagnosis. Customer reported abnormal cells outside of the 22 fields of view (fov). Case presented had very few dysplastic cells that were present on the slide in the background of obscuring lubricant and scant cellularity. The hologic cytology applications specialist reviewed the slide and determined the slide is possibly unsatisfactory. The abnormal cells were found during qc. The slide falls into the rare event category where the cells in question would match our experience in the clinical trial as evidenced in table 8 of the thinprep imaging system operation summary and clinical information. The customer site will be monitored to determine if expected occurrences are exceeded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2014-00115 |
| MDR Report Key | 3976612 |
| Report Source | 07 |
| Date Received | 2014-07-09 |
| Date of Report | 2014-06-10 |
| Date of Event | 2014-06-01 |
| Date Mfgr Received | 2014-06-10 |
| Date Added to Maude | 2014-08-05 |
| 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 |
| 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 | 2014-07-09 |
| 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 | 2014-07-09 |