MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-10 for THINPREP 5000 PROCESSOR manufactured by Hologic, Inc.
[52838033]
Hologic field service engineer (fse) confirmed but unable to reproduce error: 6006-sh024. From customers information, 3pf the samples couldn't be recovered - patients need to be recalled. Found the following to be the most likely cause of the error: slide holder venturi. Replaced the following parts per technical documentation to resolve the error: vacuum generator slide holder. Replaced the following parts as precautionary measure: vacuum cups. Performed all required setups per technical documentation: fe transferheight, sr motor pickupslideangle, st motor pickupslideendposition. Run dooming curve to verify filter elevator transfer height per service manual processed samples to confirm operation. Instrument operational. Internal reference complaint#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[52838034]
The customer reported error code 6006-sh024 on the instrument. Tech support (ts) asked the customer to remove the input carousel (ic) clean the area, clean the slide gripper fingers and also the holding cups. Customer also confirmed that for one vial, the instrument used all the liquid and did not created a cell spot. Hologic field service engineer (fse) confirmed but unable to reproduce error: 6006-sh024. Ts called back the customer and it is confirmed that the customer will have to recall 3 patients because the instrument used all the liquid in the vial without creating the cell spot. 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 diagnosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2016-00176 |
| MDR Report Key | 5865771 |
| Date Received | 2016-08-10 |
| Date of Report | 2016-07-11 |
| Date Mfgr Received | 2016-07-11 |
| Date Added to Maude | 2016-08-10 |
| 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. SIDRA PIRACHA |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638884 |
| 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 | 2016-08-10 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-08-10 |