MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-04-30 for CELLTRACKS AUTOPREP SYSTEM 9541 manufactured by Veridex Llc.
[15628379]
Customer reported (on (b)(6) 2009) the celltracks analyzer ii (b)(4) misread the cartridge id on one magnest. Customer ran the sample on celltracks autoprep (b)(4) in a batch of 2 samples. Sample 1 had a cartridge (b)(4) and sample 2 had a cartridge id of (b)(4). When the customer placed cartridge (b)(4) on the celltracks analyzer first to be scanned, the instrument read the id as (b)(4). Customer read the magnest 3 times and still it read the id as (b)(4). The analyzer was powered down and then back on, but still the cartridge id was misread. Customer put a notation in the scanned results mentioning the patient id was incorrect. Veridex customer technical support (cts) verified no erroneous patient results was released. The customer annotated the results with the correct patient identification. Magnest, cartridge and log files have been requested from the customer for investigation.
Patient Sequence No: 1, Text Type: D, B5
[15888523]
Investigation summary: a service order was completed by the field engineer on 04/06/09. The problem could not be duplicated as the customer had already edited the cartridge number. The magnest data button when checked and tested with diagnostic test passed all tests. The instrument was operating as expected and required no repairs. Magnest, cartridge and log files were requested for further investigation. At the time of this assessment the items have not been returned by the customer. The customer was contacted by customer technical support on 4-21-09 regarding return goods authorization status. No information has been received till this date. User guide information: the customer was using a linux based system. The user guide/operator manual for linux for the celltracks analyzer ii has a warning statement on page 8 step 2 that indicates that the user should verify the information about the sample and test kit that is read from the data button. This step prevents 'incorrect' information from being reported for a particular patient. Health hazard assessment: a misread could result in the sample id from one patient being associated with a different sample. This could lead to potential sample mis-identification and may lead to the reporting of erroneous test result. In this instance, no erroneous results were reported to the physician. The customer annotated the results with the correct patient identification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004153557-2009-00002 |
| MDR Report Key | 1427400 |
| Report Source | 05 |
| Date Received | 2009-04-30 |
| Date of Report | 2009-04-03 |
| Date of Event | 2009-04-03 |
| Date Mfgr Received | 2009-04-03 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2010-05-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | RARITAN NJ 08869 |
| Manufacturer Country | US |
| Manufacturer Postal | 08869 |
| Manufacturer G1 | VERIDEX LLC |
| Manufacturer Street | 3401 MASONS MILL RD SUITE 100 |
| Manufacturer City | HUNTINGDON VALLEY PA 19006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19006 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLTRACKS AUTOPREP SYSTEM |
| Generic Name | CELLTRACKS AUTOPREP SYSTEM |
| Product Code | GKH |
| Date Received | 2009-04-30 |
| Model Number | NA |
| Catalog Number | 9541 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERIDEX LLC |
| Manufacturer Address | HUNTINGDON VALLEY PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-30 |