MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-08-16 for THINPREP IMAGING SYSTEM manufactured by Hologic, Inc..
[2989493]
Possible false negative. Abnormal cells found outside of 22 fields of view (fov). No abnormal cells present within 22 fov to prompt full scan of slide. 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 operation summary and clinical info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2012-00189 |
| MDR Report Key | 2713524 |
| Report Source | 99 |
| Date Received | 2012-08-16 |
| Date of Report | 2012-07-18 |
| Date of Event | 2012-07-18 |
| Date Mfgr Received | 2012-07-18 |
| Date Added to Maude | 2012-08-31 |
| 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 | JOHN FARR |
| Manufacturer Street | 502 S ROSA RD. |
| Manufacturer City | MADISON WI 53719 |
| Manufacturer Country | US |
| Manufacturer Postal | 53719 |
| Manufacturer Phone | 6082738933 |
| Manufacturer Street | 445 SIMARANO DR. |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01752 |
| 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 | 2012-08-16 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-16 |