MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-21 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[34021842]
A customer in (b)(6) reported error 6204-ve-20 and error 4052 on their thinprep 5000 processor. It was reported the instrument turned a vial on its side spilling the entire sample. As a result this patient is going to have to be recalled for a repeat sample as the instrument error caused the entire sample to be lost. A hologic field service engineer (fse) was dispatched. Hologic fse confirmed but unable to reproduce error. Ran all non-interactive motion tests to verify instrument operation. Performed inspection per technical documentation. Performed preventative maintenance per technical documentation. Processed samples to confirm operation. Instrument operational. 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 | 1222780-2015-00244 |
| MDR Report Key | 5314194 |
| Date Received | 2015-12-21 |
| Date of Report | 2015-12-17 |
| Date Mfgr Received | 2015-11-26 |
| Date Added to Maude | 2015-12-21 |
| 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 5000 PROCESSOR |
| Generic Name | THINPREP 5000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2015-12-21 |
| 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 | 2015-12-21 |