MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-13 for THINPREP 2000 PROCESSOR manufactured by .
[31207157]
The device is not being returned.
Patient Sequence No: 1, Text Type: N, H10
[31207158]
A customer in portugal reported that their thinprep 2000 processor was not operational and requested service. The customer indicated there was no error code but that the instrument stopped processing samples. Hologic field service engineer (fse) was dispatched. Hologic's fse confirmed and reproduced the error and found the following to be the most likely cause of the error; crinkled tubing. Hologic's fse replaced the following parts as precautionary measure: e-chain + hpt sensor. Performed preventative maintenance per technical documentation. Ran pneumatic test and blank sample. Processed samples to confirm operation. Instrument operational. Additional information received from the fse confirmed the customer was able to recover most samples, however one patient needed to be recalled as a result of this incident. This is a reportable event since the thinprep 2000 processor did not perform as intended and 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 | 1222780-2015-00200 |
| MDR Report Key | 5221277 |
| Date Received | 2015-11-13 |
| Date of Report | 2015-11-12 |
| Date Mfgr Received | 2015-10-22 |
| Date Added to Maude | 2015-11-13 |
| 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. 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 2000 PROCESSOR |
| Generic Name | THINPREP 2000 PROCESSOR |
| Product Code | MKQ |
| Date Received | 2015-11-13 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-13 |