MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-24 for THINPREP IMAGING SYSTEM 70564-001 manufactured by Hologic Inc..
[68356622]
Serial number of the device not provided by the complainant, therefore the expiration date is not known. Serial of the disposable device not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review was unable to be conducted for the disposable device as the identification number was not provided by the complainant. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68356623]
The customer reported observed abnormal cells that were not located in the 22 fovs selected by the imager. Hologic cytology application specialist (cas) reviewed slide ((b)(4)) as an unknown mixed with other slides. Case presented had no triggers in the 22 fovs (fields of view) to prompt an autoscan. Full review of slide during qc showed abnormal cells outside the fovs. Cas reviewed this case and discussed with lab supervisor. The agreed there were no changes seen in the 22 fov to prompt an autoscan. The slide showed a clean background with mature epithelium. One group/cluster of cells was found outside the 22 fovs that would prompt an auto scan. The case was diagnosed as low grade squamous intraepithelial lesion, (b)(6) 2016. The cas performed inspection and instrument operational.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2017-00040 |
| MDR Report Key | 6358037 |
| Date Received | 2017-02-24 |
| Date of Report | 2017-01-25 |
| Date Mfgr Received | 2017-01-25 |
| Date Added to Maude | 2017-02-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THINPREP IMAGING SYSTEM |
| Generic Name | AUTOMATED MICROSCOPE FOR CYTOLOGY |
| Product Code | MNM |
| Date Received | 2017-02-24 |
| Model Number | 70564-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-24 |