MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-24 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[32101204]
A customer in (b)(6) reported error 6209-cf-518 on their thinprep 5000 processor. It was reported the instrument turned a vial upside down spilling the entire sample and a patient needed to be recalled. The instrument was not operational and the customer requested a hologic field service engineer (fse) field to be dispatched. Hologic field service engineer (fse) was dispatched and found the following to be the most likely cause of the error. Z axis motor encoder. Replaced the following parts per technical documentation to resolve the error; z stage. Replaced the following parts as precautionary measure; gripper assy. Performed preventative maintenance per technical documentation. Performed all required setups 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 | 1222780-2015-00216 |
| MDR Report Key | 5247686 |
| Date Received | 2015-11-24 |
| Date of Report | 2015-11-23 |
| Date Mfgr Received | 2015-11-04 |
| Date Added to Maude | 2015-11-24 |
| 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 | 0 |
| Brand Name | THINPREP 5000 PROCESSOR |
| Generic Name | THINPREP 5000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2015-11-24 |
| 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 | 2015-11-24 |