MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-14 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[55117393]
Hologic field service engineer (fse) confirmed but unable to reproduce error. Found the following to be the most likely cause of the error. Instrument in need of the camera upgrade. Performed tsb 00882 2d camera upgrade. Performed all required setups per technical documentation. Processed samples to confirm operation. Instrument operational. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[55117394]
A customer in (b)(6) reported an instance of their thinprep 5000 processor did not produce an error code. Customer requested hologic field service engineer (fse) to be dispatched to investigate. Fse was dispatched. The fse confirmed but unable to reproduce error. Found the following to be the most likely cause of the error. Instrument in need of the camera upgrade. Performed tsb 00882 2d camera upgrade and instrument operational. Even though there was no patient recall and delay in diagnosis the device did not function as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00228 |
| MDR Report Key | 5950401 |
| Date Received | 2016-09-14 |
| Date of Report | 2016-07-28 |
| Date Mfgr Received | 2016-07-27 |
| Date Added to Maude | 2016-09-14 |
| 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 | 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 5000 PROCESSOR |
| Generic Name | THINPREP 5000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2016-09-14 |
| 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 | 2016-09-14 |