MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-01-22 for THINPREP IMAGING SYSTEM manufactured by Hologic Inc.
[3229467]
Complaint issue id # (b)(4). Possible false negative. Customer and author of (b)(4) not identified. Imager and thinprep functioned as intended and met their performance specifications. The pap test is designed to screen for changes in the cells of the cervix and hologic's imaging system is designed to assist in primary cervical cancer screening of thinprep pap test slides. The imager is not designed to specifically identify cell types outside of the uterine cervix and because the description of these extra cervical cell clusters in question is "plain and obvious", the imager most likely would not have identified them as objects of interest for the cytotechnologist to review. As indicated in hologic's marketing literature and instructions for use both imager and cytotechnologist review are needed to ensure accurate results. Hologic believes that a vast majority of all studies published support its thinprep and imager claims and that its marketing claims are consistent with its packaging insert and pivotal study.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2013-00017 |
| MDR Report Key | 2935849 |
| Report Source | 00 |
| Date Received | 2013-01-22 |
| Date of Report | 2012-12-23 |
| Date of Event | 2012-01-01 |
| Date Mfgr Received | 2012-12-23 |
| Date Added to Maude | 2013-02-12 |
| 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 |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638853 |
| 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 | 2013-01-22 |
| 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 | 1. Other | 2013-01-22 |