MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-22 for THINPREP 2000 PROCESSOR manufactured by Hologic, Inc.
[34162671]
A customer in the us reported their thin prep 2000 processor broke patient slides after creating the cell spot. There was not enough sample to reprocess so a patient needed to be recalled for additional sample collection. Hologic's field service engineer reported the incident was due to slide sensor flag colliding with sensor; adjusted flag to prevent collision; ran pneumatic and blank sample tests for verification; instrument operational. Us: this is a reportable event since the thin prep 2000 processor did not perform as intended and the patient needed to be recalled for additional sample collection, which resulted in a delay in patient diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2015-00245 |
| MDR Report Key | 5318152 |
| Date Received | 2015-12-22 |
| Date of Report | 2015-12-22 |
| Date Mfgr Received | 2015-12-01 |
| Date Added to Maude | 2015-12-22 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EVA MAXWELL |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP 2000 PROCESSOR |
| Generic Name | THINPREP 2000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2015-12-22 |
| 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 | 2015-12-22 |