MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2008-02-05 for AXSYM DRUGS OF ABUSE TOXICOLOGY ASSAY DISK 3D54-08 manufactured by Abbott Laboratories.
[786175]
The customer stated the axsym analyzer yielded a vrtx error 002 in task 40 which halted operation of the analyzer. The customer was running an amphetamine assay after installing and calibrating a new lot without issue. The customer was instructed to cycle power. A new diskette was sent to the customer who uninstalled and reinstalled the amphetamine assay to resolve the issue. No impact to pt management was reported.
Patient Sequence No: 1, Text Type: D, B5
[8045297]
This is an initial report. An investigation is in progress. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2008-00023 |
| MDR Report Key | 991062 |
| Report Source | 01,04 |
| Date Received | 2008-02-05 |
| Date of Report | 2008-01-15 |
| Date of Event | 2007-12-24 |
| Date Mfgr Received | 2008-01-15 |
| Date Added to Maude | 2008-07-22 |
| 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 | 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 Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 992340 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-05 |