MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-02-05 for AXSYM DRUGS OF ABUSE TOXICOLOGY ASSAY DISK 3D54-08 manufactured by Abbott Laboratories.
[802987]
The customer stated vrtx error 002 in task 40 occurred on the axsym analyzer three times after installing the drugs of abuse (doa) assay disk version 8. 0 and calibrating the assay. The customer cycled power and reinstalled the software without issue, but encountered the error again when running the amphetamine assay. Abbot field service formatted the hard drive, reloaded axsym system software version 6. 0, and reloaded the doa assay disk version 8. 0. When the cutoff parameters were adjusted after service, the error reoccurred. A copy of the system software in use was returned to abbott for further investigation. No impact to pt management was reported.
Patient Sequence No: 1, Text Type: D, B5
[8045292]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2008-00010 |
| MDR Report Key | 991046 |
| Report Source | 04 |
| Date Received | 2008-02-05 |
| Date of Report | 2008-01-15 |
| Date of Event | 2007-12-20 |
| Date Mfgr Received | 2008-01-15 |
| Date Added to Maude | 2008-07-03 |
| 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 | 0 |
| Manufacturer Contact | SUDARSHAN HEBBAR, MD, D-3MQC, AP6B |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479379677 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 1415939-2/01/08-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXSYM DRUGS OF ABUSE TOXICOLOGY ASSAY DISK |
| Generic Name | AMPHETAMINE TEST SYSTEM |
| Product Code | MGX |
| Date Received | 2008-02-05 |
| Model Number | NA |
| Catalog Number | 3D54-08 |
| Lot Number | NA |
| ID Number | VERSION 8.0 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 992323 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-05 |