MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-06-16 for CELLSEARCH CIRCULATING TUMOR CELL KIT 7900001 manufactured by Veridex Llc.
[20770983]
Customer reporting an event of discrepant results obtained from 2 scans of the same sample to the kit lot# 0107 by the cell tracks analyzer. Customer indicates that the described event occurred in '08. The sample was scanned in cartridge no: 361476. Customer reporting the first scan to be of 1126 unassigned events with 302 ctc's. The second scan yielded 1067 unassigned events with 238 ctc's. Customer did not disclose as to why the sample was scanned. The customer indicates that the specimen was scanned because of the concern of the high number of ctc's. Cts did confirm that the second scan with the ctc count of 238 was reported.
Patient Sequence No: 1, Text Type: D, B5
[20819359]
Customer reported the incident for documentation only, and does not request additional investigation by veridex. An rga was issued by cts, but returned material was not received from the customer. No service activity performed. Event not be investigated further at this time. Customer indicates that the cartridge is available, but does not wish for any additional investigation by veridex as a result of the cartridge being so old. Customer only reporting the event for documentation of the concern. Cts advised the customer that the concern/event would be documented. The customer has agreed to contact cts in the event that a similar concern arises. No further action indicates by cts.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004582358-2008-00003 |
| MDR Report Key | 1061487 |
| Report Source | 06 |
| Date Received | 2008-06-16 |
| Date of Report | 2008-05-21 |
| Date of Event | 2008-05-14 |
| Date Mfgr Received | 2008-05-21 |
| Date Added to Maude | 2009-04-16 |
| 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 | DEBRA RASMUSSEN |
| Manufacturer Street | 1001 US HWY 202 NORTH |
| Manufacturer City | WARREN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9085415843 |
| Manufacturer G1 | VERIDEX, LLC |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | WARREN NJ 07059 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07059 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLSEARCH CIRCULATING TUMOR CELL KIT |
| Generic Name | CELLSEARCH CTC KIT |
| Product Code | NQI |
| Date Received | 2008-06-16 |
| Model Number | NA |
| Catalog Number | 7900001 |
| Lot Number | 0107 |
| ID Number | CARTRIDGE # 361476 |
| Device Expiration Date | 2008-11-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERIDEX LLC |
| Manufacturer Address | RARITAN NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-16 |