MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-05-19 for CELLSEARCH CIRCULATING TUMOR CELL KIT 7900001 manufactured by Veridex, Llc.
[19551904]
Customer reported two samples drawn from the same pt on (b) (6) 2008 (around 11am pst) generated results of 79 circulating tumor cells (ctc) and 4 ctc. The first test was conducted the evening of (b) (6) 2008 using ctc kit lot 0087. The second test was conducted on (b) (6) 2008 also using ctc kit lot 0087. A control was included with both tests. Blood was collected in the cellsave tube and stored at room temperature, (cellsave tube lot number 725806). No aggregation was observed. No other samples were tested on either day. The wash buffer was stored with the kit in the fridge after each use. Controls passed. Customer states that daily cleaning is performed on the autoprep. Customer indicated that the 4 ctc cell count was reported. Instruments used were autoprep (b) (4) and celltracks analyzer (b) (4).
Patient Sequence No: 1, Text Type: D, B5
[19670177]
Two cd log files of the result were returned by the customer to veridex for technical review. On-site visit by veridex representative was conducted. No definitive root cause was determined for reported discrepant results (79 ctc and 4 ctc). The system logs provided by the customer were reviewed by a veridex specialist and confirmed the ctcs of 79 and 4 respectively as identified by the customer. During on site visit conducted by veridex, sample preparation and analysis was observed. The observation indicated that the procedure being used by the customer was not in accordance with the user training with respect to sample separation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004582358-2008-00002 |
| MDR Report Key | 1051758 |
| Report Source | 06 |
| Date Received | 2008-05-19 |
| Date of Report | 2008-05-16 |
| Date of Event | 2008-04-18 |
| Date Mfgr Received | 2008-04-23 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2010-04-01 |
| 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 RASMSSEN |
| Manufacturer Street | 1001 US HWY 202 NORTH |
| Manufacturer City | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer Phone | 9085415843 |
| Manufacturer G1 | VERIDEX, LLC |
| Manufacturer Street | 33 TECHNOLOGY DR. |
| 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 | 2008-05-19 |
| Model Number | NA |
| Catalog Number | 7900001 |
| Lot Number | 0087 |
| ID Number | NA |
| Device Expiration Date | 2008-07-16 |
| 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 | 2008-05-19 |