MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-09 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[62386221]
Hologic's field service engineer (fse) went to the facility and confirmed 6007/se026 and reproduced error. The fse found the most likely cause of the error slide rotator flag crashing with home sensor. The fse adjusted slide rotator to solve the issue. The fse also performed wizard for slide handoff to scara and wizard for carousel slide/vial/filter, as the instrument need. The fse ran all non-interactive tests to verify instrument operation. Processed samples to confirm operation (around 250). Instrument operational. Internal reference complaint: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[62386222]
It was reported on (b)(6) 2016, the customer was running a batch overnight and the slides were left outside the fixative bath. The following day the customer saw a system error code 6007-se026 and also 6513-co547 on assy autoloader ready t5000. The patient needed to be recalled. Hologic's field service engineer (fse) called to attend site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00269 |
| MDR Report Key | 6159239 |
| Date Received | 2016-12-09 |
| Date of Report | 2016-11-11 |
| Date Mfgr Received | 2016-11-11 |
| Date Added to Maude | 2016-12-09 |
| 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 | 2016-12-09 |
| 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 | 2016-12-09 |