MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-04-25 for CELLIENT 71663-001 manufactured by Cytyc Corp., A Family Of Hologic Companies.
[20164062]
False negative on ivdd: the customer reported there was no diagnostic material on the cellient cell blocks. The customer has had 3 cases (2 pleural fluids and 1 lymph node fna) that were malignant on traditional cell block and the thinprep non gyn (tpng) slide but the cellient blocks just had inflammation. The customer split the samples from the fresh specimen, processed according to recommended protocol, added the appropriate specimen to the tpng vial as well as made a concurrent cellient vial. The tpng slides were diagnostic on all 3 specimens, the fna and one of the pleural fluids were malignant and the other pleural fluid was diagnosed as suspicious. The lab processed traditional cell blocks using histogel as well as cellient. All 3 of the traditional blocks were diagnosed the same as the tpng, however, the cellient blocks did not have any diagnostic material. The lab reprocessed the malignant fluid using the residual material in the cellient vial and the residual material from the tp vial and there were still no diagnostic cells on the 2nd cellient block. The hologic clinical application specialist microscopically reviewed the 3 cases with the customer and confirmed the appearance of the slides. The customer was observing proper prep protocol using the thinprep 2000 operator's manual and the quick reference guides and recommended protocol for tpng and cellient.
Patient Sequence No: 1, Text Type: D, B5
[20447992]
Device is being evaluated. Add'l info will be submitted as relevant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2008-00054 |
| MDR Report Key | 1034406 |
| Report Source | 06 |
| Date Received | 2008-04-25 |
| Date of Report | 2008-04-24 |
| Date of Event | 2008-04-15 |
| Date Mfgr Received | 2008-04-15 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2008-10-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RAJ KASBEKAR, MGR |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638858 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLIENT |
| Generic Name | TISSUE PROCESSING EQUIPMENT |
| Product Code | KET |
| Date Received | 2008-04-25 |
| Model Number | 71663-001 |
| Catalog Number | NI |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1036920 |
| Manufacturer | CYTYC CORP., A FAMILY OF HOLOGIC COMPANIES |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-04-25 |