MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-01-06 for THINPREP IMAGING SYSTEM manufactured by Hologic Inc..
[4216750]
No delay in pt diagnosis. Customer reported three cases of slides with diagnostic cells outside the 22 fields of view (fov). The three cases were manually reviewed due to abnormal history. The supervisor reported she reviewed the slides and there were no abnormal cells represented in the 22 fov. Rare ascus was found on manual review. The customer will continue to monitor but did not want to follow up further at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2014-00006 |
| MDR Report Key | 3565155 |
| Report Source | 99 |
| Date Received | 2014-01-06 |
| Date of Report | 2013-12-13 |
| Date of Event | 2013-01-01 |
| Date Mfgr Received | 2013-12-13 |
| Date Added to Maude | 2014-01-10 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP IMAGING SYSTEM |
| Generic Name | IMAGER |
| Product Code | MNM |
| Date Received | 2014-01-06 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-01-06 |