MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-23 for THINPREP IMAGING SYSTEM 71050-001 manufactured by Hologic Inc..
[78457045]
Internal complaint reference#(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[78457046]
The customer reported thinprep imaging station was intermittently breaking slides in half damaging cell spots. The customer also claims system randomly reboots itself, but did not have all the details (i. E. Error codes, etc). According to the customer several slides over several weeks were broken and cell spots were damaged. The customer was forced to recollect patient specimens. Hologic field service engineer (fse) went to the customer unable to confirm or reproduce error. The fse ran 20 service slides and checked settings. No problem was found. System operational.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2017-00160 |
| MDR Report Key | 6662786 |
| Date Received | 2017-06-23 |
| Date of Report | 2017-05-26 |
| Date Mfgr Received | 2017-05-26 |
| Date Added to Maude | 2017-06-23 |
| 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 | 2017-06-23 |
| Model Number | 71050-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-06-23 |