MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-09-01 for THINPREP IMAGING SYSTEM manufactured by .
[24709677]
Customer notified hologic of a slide with abnormal cells that were not located in the 22 fields of view (fov). Although the customer reported the event to hologic on (b)(6) 2015, the slide was from (b)(6) 2014. The customer discovered the slide during qc. This is a potential delay in diagnosis. Hologic's cytology application specialist (cas) reviewed the slide with a mix of other slides. The cas agreed that there were no abnormal cells in the 22 fov to prompt an autoscan (full review) of the slide. Customer does not want to submit the slide to hologic for further review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2015-00155 |
| MDR Report Key | 5045814 |
| Report Source | USER FACILITY |
| Date Received | 2015-09-01 |
| Date of Report | 2015-08-31 |
| Date of Event | 2015-08-05 |
| Date Mfgr Received | 2015-08-05 |
| Date Added to Maude | 2015-09-01 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA MARABELLA |
| 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 | 2015-09-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-01 |