MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-02-04 for AXSYM DRUGS OF ABUSE TOXICOLOGY ASSAY DISK 3D54-08 manufactured by Abbott Laboratories.
[18883039]
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
[18969052]
A new abbott axsym drugs of abuse (doa) toxicology assay disk, version 8. 0 was released on 11/26/07 which contained a revised axsym. Amphetamine/methamphetamine ii assay file. Installation of the revised assay file is required prior to use of the axsym amphetamine reagents. Complaints have been received indicating when the axsym amphetamine positive and negative interpretation cutoff parameter are edited, error messages are generated before assay runs are completed, resulting in an instrument lock-up. A product correction was issued and reported under 21cfr806 to the fda on february 1, 2008. Abbott has not received any reports of adverse events related to the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2008-00006 |
| MDR Report Key | 990366 |
| Report Source | 07 |
| Date Received | 2008-02-04 |
| Date of Report | 2008-01-18 |
| Date of Event | 2008-01-18 |
| Date Mfgr Received | 2008-01-18 |
| Date Added to Maude | 2008-08-05 |
| 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 | 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 |
| 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 | DKZ |
| Date Received | 2008-02-04 |
| Model Number | NA |
| Catalog Number | 3D54-08 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 992325 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-04 |