MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-12 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[52854439]
Investigation performed. The instrument finished 14 samples run without error when arrived. Performed inspection per technical documentation + global cleaning. Found rusted compressor + trace of leak below. Replaced the following parts as precautionary measure: compressor. Ran go no-go test to verify instrument operation. Processed samples to confirm operation. Instrument operational. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[52854440]
A customer in (b)(6) reported error 6225fr016 and 6801ft026 on their thinprep 5000 processor. Customer did it and reported that slide was not done and was emptied. No sample and patient need to be recalled. While rebooting tech support (ts) heard a strong noise and suspected that's the compressor not working properly. Ts asked customer to try to run a test sample but user interface came frozen. Machine not operational. Hologic field service engineer (fse) need to be dispatched. Although the instrument produced an error code during this incident, this is a reportable event since 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 | 1222780-2016-00205 |
| MDR Report Key | 5872688 |
| Date Received | 2016-08-12 |
| Date of Report | 2016-07-13 |
| Date Mfgr Received | 2016-07-13 |
| Date Added to Maude | 2016-08-12 |
| 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 | 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 | 2016-08-12 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-08-12 |