MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-05-22 for THINPREP IMAGING SYSTEM manufactured by Hologic.
[3449722]
Lab tech mentioned finding 25-40 missed lsil over an approx 6 month time frame. Cytology application support specialist (cas) was unable to and was not in a position to research and determine if there were triggers in the 22 fields of view. Customer did not have time or resources to trouble shoot at this time but will gather the info at a future time when they are ready to investigate. Since there are multiple initiatives now going on in the lab, cas suggested we revisit in the near future. Cas will follow-up again with this customer within 60 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2013-00093 |
| MDR Report Key | 3130017 |
| Report Source | 06 |
| Date Received | 2013-05-22 |
| Date of Report | 2013-05-01 |
| Date of Event | 2012-12-01 |
| Date Mfgr Received | 2013-05-01 |
| Date Added to Maude | 2013-06-19 |
| 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 | RANDALL COVILL, MGR |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638853 |
| Manufacturer G1 | HOLOGIC |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01752 |
| Single Use | 0 |
| 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 | 2013-05-22 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-22 |