MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-15 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[75381695]
Device history record (dhr) review was conducted for the reported identification number. The serial number was released meeting all qa specifications.
Patient Sequence No: 1, Text Type: N, H10
[75381696]
It was reported by the customer that the thinprep 5000 is "losing samples". The hologic field service engineer (fse) replaced a new type of filter rotator motor to resolve the error message. The fse also replaced a weak compressor to solve the frequent startup problem 6802-mt016. Checked all setups. Performed all pneumatic tests and all interactive motion tests. Advised customer to not use leica racks in our bath. The samples were processed samples to confirm operation. Instrument operational. This is a reportable event since the thinprep 5000 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
[76837699]
Additional information received and based on the investigation there was no malfunction and no patient and no patient recall the event was reassessed to 'not reportable".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2017-00118 |
| MDR Report Key | 6567391 |
| Date Received | 2017-05-15 |
| Date of Report | 2017-04-20 |
| Date Mfgr Received | 2017-05-18 |
| Device Manufacturer Date | 2009-10-15 |
| Date Added to Maude | 2017-05-15 |
| 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 | SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082633884 |
| 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 | 2017-05-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-05-15 |