MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-25 for THINPREP 3000 PROCESSOR manufactured by Hologic, Inc.
[46292361]
A customer in the us reported an instance of their thinprep 3000 processor producing error code se 16 24 15 00 (an operation failed during batch processing, pms pump im#0. The customer further stated that two patient samples were entirely drawn into the system forcing a recollection of samples. Hologic field service engineer (fse) dispatched to customer site. Found the spa waste fitting excluded to be the most likely cause of the error. Cleared the waste fitting exclusion to resolve the error. Ran pneumatic test and blank sample. Processed samples to confirm operation. Instrument operational. Although the instrument produced an error code during this incident, this is a reportable event since two patients 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 | 1222780-2016-00135 |
| MDR Report Key | 5678926 |
| Date Received | 2016-05-25 |
| Date of Report | 2016-05-24 |
| Date Mfgr Received | 2016-05-03 |
| Date Added to Maude | 2016-05-25 |
| 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 3000 PROCESSOR |
| Generic Name | THINPREP 3000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2016-05-25 |
| 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 | 2016-05-25 |