MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2017-11-03 for THINPREP IMAGING SYSTEM 70564-001 manufactured by Hologic Inc..
[91008662]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91008663]
The customer reported observed abnormal cells that were not located in the 22 fovs selected by the imager. Hologic cytology application specialist (cas) is still in the process of gathering information. Hologic field service engineer (fse) went to the customer and was unable to find any abnormally with scope function/performance. Performed all setups per technical documentation as a precautionary measure. Ran autocycler and reviewed a test slide to confirm operation. Instrument operational.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2017-00143 |
| MDR Report Key | 7000589 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2017-11-03 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-05-16 |
| Date Mfgr Received | 2017-05-16 |
| Date Added to Maude | 2017-11-03 |
| 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 | 3 |
| Brand Name | THINPREP IMAGING SYSTEM |
| Generic Name | AUTOMATED MICROSCOPE FOR CYTOLOGY |
| Product Code | MNM |
| Date Received | 2017-11-03 |
| 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 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-03 |