FDA Adverse Event
Other
Summary report: N
THINPREP IMAGING SYSTEM
MDR report key: 2012238
·
Received February 25, 2011
Report
- Report Number
- 1222780-2011-00038
- Event Type
- Other
- Date Received
- February 25, 2011
- Date of Event
- January 4, 2011
- Report Date
- January 13, 2011
- Manufacturer
- HOLOGIC, INC.
- Product Code
- MNM
- PMA / PMN Number
- P020002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ABNORMAL CELLS WERE FOUND OUTSIDE OF THE 22 FIELDS OF VIEW (FOV). NO TRIGGER CELLS WERE PRESENT TO PROMPT A FULL SCAN OF THE SLIDE. THERE WAS NO DELAY IN PT DIAGNOSIS AS THE DIAGNOSTIC CELLS WERE FOUND DURING QC. CUSTOMER IS SENDING A SLIDE TO HOLOGIC FOR REVIEW. THIS SITE WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THINPREP IMAGING SYSTEM | AUTOMATED MICROSCOPE FOR CYTOLOGY | MNM | HOLOGIC, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |